센소릴 아쉬와간다

Effects of an Aqueous Extract of Withania somnifera on Strength Training Adaptations and Recovery: The STAR Trial.

1. Nutrients. 2018 Nov 20;10(11):1807. doi: 10.3390/nu10111807. Effects of an Aqueous Extract of Withania somnifera on Strength Training Adaptations and Recovery: The STAR Trial. Ziegenfuss TN(1), Kedia AW(2), Sandrock JE(3), Raub BJ(4), Kerksick CM(5), Lopez HL(6). Author information: (1)The C

Safety Evaluation of an Aqueous Root and Leaf Extract of Ashwagandha (Withania somnifera).

2. Phytother Res. 2026 Apr 15. doi: 10.1002/ptr.70314. Online ahead of print. Safety Evaluation of an Aqueous Root and Leaf Extract of Ashwagandha (Withania somnifera). Summan M(1), Doepker CL(2), Brorby GP(3). Author information: (1)Kerry Group, Global Technology & Innovation Centre, Naas, Co.

Formulation of Biscuits With Withania somnifera Root Powder: Polyphenols, Enzyme Inhibition, Antioxidant Capacity, and Acrylamide Formation.

1. J Food Sci. 2026 May;91(5):e71068. doi: 10.1111/1750-3841.71068. Formulation of Biscuits With Withania somnifera Root Powder: Polyphenols, Enzyme Inhibition, Antioxidant Capacity, and Acrylamide Formation. Adigozali M(1), Fadaei V(2), Saremnezhad S(1). Author information: (1)Department of Food Science and Technology, TeMS.C., Islamic Azad University, Tehran, Iran. (2)Department of Food Science and Technology, ShQ.C., Islamic Azad University, Shahr-e Qods, Iran. This study evaluated the application of Ashwagandha, Withania somnifera, root powder (ARP) at different levels 0% (B0 = control), 3% (B3), and 5% (B5) (W/W) in the production of biscuits as a popular snack. The results indicated that lightness increased, browning index decreased, and a significant reduction in pH was observed in these samples enriched. Compared to the control, acrylamide content (AAC) decreased in B2 and B3. Additionally, the nutritional value and the bioactive properties (total polyphenol content, α-amylase and α-glucosidase inhibitory activity, and antioxidant activity) of the enriched biscuit samples improved compared to the control. Overall, it can be concluded that by incorporating ARP into the biscuit formulations allows for the production of functional biscuit while retaining the nutritional benefits of ARP. PRACTICAL APPLICATIONS: In this study, an attempt was made to produce a biscuit that benefits from the nutritional and health-promoting effects of the root of the Ashwagandha, considering the health-promoting and antioxidant effects and the presence of bioactive substances in it, and due to the easy production and availability of biscuits for different segments of society; in addition, it can also respond positively to consumer demand for health-oriented products. It should be noted that if consumers are aware of the beneficial nutritional and health effects of plant food ingredients in food, it will be possible to accept even larger amounts of these functional additives in the final product. © 2026 Institute of Food Technologists. DOI: 10.1111/1750-3841.71068 PMID: 42053352 [Indexed for MEDLINE]

Comparative Evaluation of Ashwagandha (Withania somnifera) Root Extract and Melatonin for Improving Sleep Quality in Adults: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study.

2. Clocks Sleep. 2026 Mar 27;8(2):15. doi: 10.3390/clockssleep8020015. Comparative Evaluation of Ashwagandha (Withania somnifera) Root Extract and Melatonin for Improving Sleep Quality in Adults: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study. Movva N(1), Salve J(2), Wankhede K(3), Thakare V(1), Langade D(1). Author information: (1)Department of Pharmacology, DY Patil University School of Medicine, Nerul, Navi Mumbai 400706, India. (2)Department of Internal Medicine, Prakruti Care Hospital, Navi Mumbai 400605, India. (3)Department of General Medicine, Bharati Vidyapeeth Deemed University Dental College & Hospital, Navi Mumbai 400614, India. Ashwagandha, a revered herb in Ayurvedic medicine for over 3000 years, is recognized for its potential benefits in regulating sleep and supporting overall vitality. This study evaluated the comparative effects of Ashwagandha root extract (ARE) and melatonin (MLT) on sleep quality in adults. In this prospective, randomized, double-blind, placebo-controlled trial, 200 men and women aged 18-50 years were randomized to receive ARE (300 mg twice daily; n = 50), MLT (3 mg/day; n = 50), a combination of ARE (600 mg/day) and MLT (3 mg/day; n = 50), or placebo (n = 50) for eight weeks. The primary outcome was the change in sleep onset latency (SOL) from baseline to week eight, measured by actigraphy. Secondary outcomes included actigraphy-based changes in total sleep time (TST), wake after sleep onset (WASO), and sleep efficiency (SE), as well as subjective measures such as the Pittsburgh Sleep Quality Index (PSQI) and the Hamilton Anxiety Scale (HAM-A). At week eight, SOL was significantly reduced across treatment groups, with the ARE-MLT (p < 0.0001) combination showing the greatest improvement. The combination group also demonstrated significant improvements in TST (p < 0.0001), WASO (p < 0.0001), and SE (p < 0.0001), whereas ARE and MLT monotherapy produced moderate but comparable benefits. Inferential analyses confirmed statistically significant improvements in objective and subjective sleep measures (p < 0.0001). Safety analyses indicated that mild adverse events occurred across all groups, with no clinically significant between-group differences. Overall, both Ashwagandha and melatonin improved sleep disturbances in adults, with combination therapy producing the most consistent and pronounced benefits. DOI: 10.3390/clockssleep8020015 PMCID: PMC13108063 PMID: 42029558 Conflict of interest statement: The authors declare no conflicts of interest.

Withania somnifera Root Extract Ameliorates PTU-Induced Hypothyroidism by Regulating Hormone Levels and Gene Expression in Rats.

3. Food Sci Nutr. 2026 Apr 17;14(4):e71732. doi: 10.1002/fsn3.71732. eCollection 2026 Apr. Withania somnifera Root Extract Ameliorates PTU-Induced Hypothyroidism by Regulating Hormone Levels and Gene Expression in Rats. Hossain MS(1), Shuvo MSP(1), Talukder MMH(1), Shahidullah(1), Jannat S(1), Niaz SMR(1), Sohel M(1), Islam MK(1). Author information: (1)Department of Biochemistry and Molecular Biology Mawlana Bhashani Science and Technology University Tangail Bangladesh. Hypothyroidism is a prevalent endocrine disorder characterized by the inadequate production of thyroid hormones (T3 and T4), leading to various physiological dysfunctions. Current treatments often involve synthetic hormone replacement, which is limited by some adverse effects. This study investigated the therapeutic efficacy of a methanolic extract of Withania somnifera root (MEWS) in propylthiouracil (PTU)-induced hypothyroid rats. Forty rats were divided into five groups (n = 8): (1) negative control (NC), receiving no treatment; (2) positive control (PC), administered 0.05% w/v PTU to induce hypothyroidism; (3) W. somnifera control (WSC), treated with 500 mg/kg/day MEWS alone; (4) W. somnifera treatment (WST-500), receiving 500 mg/kg/day MEWS alongside PTU; and (5) combination therapy (CT-500), treated with both 500 mg/kg/day MEWS and 0.05% w/v PTU. Serum hormones (TSH, T3, T4) were measured by ELISA, thyroid histopathology was analyzed, and thyroperoxidase (TPO) and thyroglobulin (TG) gene expression were quantified by qPCR. Molecular docking and ADMET profiling were employed to identify bioactive phytochemicals that target the thyroid-stimulating hormone receptor (TSHR) and Type 2 iodothyronine deiodinase (D2). PTU induction significantly increased thyroid weight (175.8%), TSH levels (4.45-fold), and TPO/TG expression (4.28 and 3.10-fold), while reducing T3 and T4 (82% and 75%; all p < 0.05). MEWS treatment (WST-500) significantly reversed these effects, reducing thyroid weight (55.8%), TSH (74.2%), and TPO/TG expression, while restoring T3 and T4 levels to near-normal (p < 0.05). Histopathology revealed reduced fibrosis and improved follicular architecture. A computational study identified phytochemicals with strong binding affinities for TSHR and D2 and favorable ADMET properties. These findings suggest that MEWS may ameliorate hypothyroidism by regulating hormone levels, gene expression, and thyroid morphology, indicating its potential as an adjunct or alternative to conventional hormone replacement therapies for hypothyroidism. © 2026 The Author(s). Food Science & Nutrition published by Wiley Periodicals LLC. DOI: 10.1002/fsn3.71732 PMCID: PMC13088288 PMID: 42005335 Conflict of interest statement: The authors declare no conflicts of interest.

Cytotoxic Potential Evaluation of Innovative Pressurised Cyclic Solid-Liquid Extracts from Withania somnifera.

4. Plants (Basel). 2026 Mar 26;15(7):1027. doi: 10.3390/plants15071027. Cytotoxic Potential Evaluation of Innovative Pressurised Cyclic Solid-Liquid Extracts from Withania somnifera. Culurciello R(1), Power K(1), Esposito S(1), Di Nardo I(1), Landi S(1), De Vico G(1), Palatucci D(1), Pizzo E(1), Naviglio D(2), Zarrelli A(2). Author information: (1)Department of Biology, University of Naples Federico II, Via Cintia 4, I-80126 Naples, Italy. (2)Department of Chemical Sciences, University of Naples Federico II, Via Cintia 4, I-80126 Naples, Italy. ETHNOPHARMACOLOGICAL RELEVANCE: Withania somnifera (L.) Dunal, widely used in traditional medical systems such as Ayurveda, Unani, and Middle Eastern folk medicine, is valued for its adaptogenic, anti-inflammatory, neuroprotective, antimicrobial, and anticancer properties. These activities are primarily attributed to withanolides, with Withaferin A recognized as one of the most bioactive constituents. Although traditional preparations often rely on the root, leaf use provides a more sustainable alternative and may yield significant quantities of active metabolites. Identifying efficient, modern extraction technologies that can enhance the recovery of bioactive compounds from leaves is essential for developing effective, standardized ethnopharmacological formulations. MATERIALS AND METHODS: Plants of W. somnifera grown from seeds were subjected to different environmental conditions (control, drought, cold, yeast extract treatment). Leaves were extracted using Pressurized Cyclic Solid-Liquid Extraction (PCSLE) with hydroalcoholic solvents and compared with conventional infusion of dried leaves. Extracts were fractionated with solvents of varying polarity and analyzed by TLC, HPLC, and NMR for quantification of Withaferin A. Expression levels of key withanolide-biosynthetic genes (CAS, SMT1, DWARF1, CYP71, CYP76) were assessed using qRT-PCR. Antimicrobial activity of pure Withaferin A, aqueous extract, and hydroalcoholic PCSLE extract was evaluated through MIC and MBC assays against Gram-positive and Gram-negative strains. Cytotoxic activity was measured via MTT assays in six human cancer cell lines after 3, 6, and 24 h of treatment. RESULTS: PCSLE yielded substantially higher levels of Withaferin A than traditional infusion, especially in medium-polarity fractions (chloroform and ethyl acetate), with concentrations reaching 0.70% in fresh leaf mass (4.8% dry weight), compared to 0.11% obtained by infusion. Gene expression analysis revealed that 24-week-old plants exhibited the highest transcription of withanolide-biosynthetic genes, and drought stress significantly upregulated CAS, SMT1, DWARF1, CYP71, and CYP716, indicating enhanced metabolic flux toward withanolide production. Hydroalcoholic PCSLE extracts showed broad-spectrum antimicrobial activity, with MIC and MBC values comparable to pure Withaferin A and demonstrating bactericidal effects against Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, and Listeria monocytogenes. The aqueous extract showed activity only against Gram-positive strains. Cytotoxicity assays demonstrated an optimistic, dose-dependent reduction in cell viability across all tumour cell lines treated with the hydroalcoholic PCSLE extract, closely mirroring the activity of pure Withaferin A and consistently exceeding the effect of the aqueous extract. IC50 values confirmed the high bioactive content of PCSLE extracts and suggested mechanisms like those known for Withaferin A. CONCLUSIONS: PCSLE proved to be a highly efficient extraction technology for obtaining leaf extracts rich in Withaferin A, outperforming conventional extraction methods while exploiting sustainable plant tissue. Developmental stage and drought stress significantly modulated the expression of genes involved in withanolide biosynthesis, highlighting agronomic strategies capable of enhancing metabolite production. Hydroalcoholic PCSLE extracts exhibited antimicrobial and cytotoxic activities comparable to pure Withaferin A, supporting their relevance as promising therapeutic candidates. These findings advocate for the use of W. somnifera leaves as a sustainable source of bioactive compounds and demonstrate that advanced extraction technologies can contribute to the development of innovative ethnopharmacological preparations for antimicrobial and anticancer applications. DOI: 10.3390/plants15071027 PMCID: PMC13074650 PMID: 41977686 Conflict of interest statement: The authors have no conflicts of interest to declare.

Safety of 8-Week Administration With Ashwagandha (Withania somnifera) Root Extract in Adults With Stress and Anxiety: Findings From a Prospective, Randomized, Multi-Center, Double-Blinded, Placebo-Controlled Study.

5. Phytother Res. 2026 Apr 6. doi: 10.1002/ptr.70315. Online ahead of print. Safety of 8-Week Administration With Ashwagandha (Withania somnifera) Root Extract in Adults With Stress and Anxiety: Findings From a Prospective, Randomized, Multi-Center, Double-Blinded, Placebo-Controlled Study. Pakhale K(1), Salve J(1), Ademola J(2), Parraca J(3), Langade D(1). Author information: (1)DY Patil University School of Medicine, Navi Mumbai, Maharashtra, India. (2)SF Research Institute, San Francisco, California, USA. (3)University of Évora, Évora, Portugal. Ashwagandha (Withania somnifera) has been recognized for enhancing physical strength, mental well-being, and overall vitality. Despite its long-standing use across generations, some clinical reports have noted occasional adverse events. This study compared the safety and tolerability of Ashwagandha Root Extract (ARE) in healthy adults. This was a prospective, multicenter, multinational, randomized, double-blinded, placebo-controlled study (n = 1002; 18 to 65 years). Participants with reported stress and anxiety were randomly assigned to receive either 600 mg/day (two divided doses) of ARE (n = 498) or a placebo (PL, n = 504) orally for 8 weeks. The primary outcome was the safety profile assessed through laboratory parameters and adverse events (AEs), while tolerability was assessed by the participants on a 7-point Likert scale of Global Assessment of Tolerability to Therapy. Demographic and baseline characteristics were similar between groups. No serious adverse events were reported; a total of 74 AEs (7.4%) were documented, with 46 events (9.2%) in the PL group and 28 events (5.6%) in the ARE group. The most common AEs include nausea (3.2% in PL vs. 2.0% in ARE), dry mouth (1.4% in both groups), and headache (2.2% in PL vs. 0.2% in ARE). Laboratory evaluations showed no significant changes in liver function tests, renal function markers, or hematological parameters between the ARE and PL groups. Both groups maintained normal ranges for key biomarkers, including aspartate aminotransferase, alanine aminotransferase, creatinine, and hemoglobin levels throughout the study duration. Tolerability ratings showed no statistically significant difference between the groups (p = 0.487), and most of the participants rated the ARE therapy as "Good" or "Excellent." ARE is well-tolerated and safe in adults with stress and anxiety. These results support the use of Ashwagandha root extract as a viable non-pharmacological treatment, warranting further exploration of its long-term effects in diverse populations. © 2026 The Author(s). Phytotherapy Research published by John Wiley & Sons Ltd. DOI: 10.1002/ptr.70315 PMID: 41943502

Effects of 8 days of Ashwagandha supplementation on strength, fatigue, soreness, and recovery in amateur handball players: A double-blind, randomized, placebo-controlled trial.

6. Nutr Health. 2026 Apr 6:2601060261439102. doi: 10.1177/02601060261439102. Online ahead of print. Effects of 8 days of Ashwagandha supplementation on strength, fatigue, soreness, and recovery in amateur handball players: A double-blind, randomized, placebo-controlled trial. Ferreira JF(1), Maia F(1)(2), Ferreira RM(1)(3)(4), Martinho DV(5)(6)(7)(8), Fernandes LG(1), Leão C(1)(2)(9), Pimenta N(1). Author information: (1)Polytechnic Institute of Maia, N2i, Social Sciences, Education and Sports School, Avenida Carlos de Oliveira Campos, Castêlo da Maia, Maia, Portugal. (2)Research Center in Sports Sciences, Health Sciences and Human Development, University of Maia, Maia, Portugal. (3)Sport Physical Activity and Health Research & Innovation Center (SPRINT), Melgaco, Portugal. (4)Scientific-Pedagogical Unit of Physiotherapy, Polytechnic Institute of Coimbra, Coimbra Health School, Coimbra, Portugal. (5)Research Unit for Sport and Physical Activity, Faculty of Sport Sciences and Physical Education, University of Coimbra, Coimbra, Portugal. (6)Laboratory of Robotics and Engineering Systems (LARSYS), Interactive Technologies Institute, Funchal, Portugal. (7)CIPER, Faculdade de Ciências do Desporto e Educação Física, Universidade de Coimbra, Coimbra, Portugal. (8)CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Cruz-Quebrada- Dafundo, Portugal. (9)Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, Viana do Castelo, Portugal. BackgroundNutritional supplements are commonly used to increase strength, recovery, and overall athletic performance. Ashwagandha (Withania somnifera), a natural adaptogen, has shown promising ergogenic potential; however, evidence in athletes-particularly over short-term periods remains limited.MethodsThis randomized, double-blind, placebo-controlled trial investigated the effects of 8 days of Ashwagandha supplementation (600 mg of standardized root extract daily) - a duration chosen to evaluate its potential utility during acute competitive periods - on neuromuscular performance and recovery in 31 male handball players (age: 20.3 ± 3.1 years). Participants ingested either Ashwagandha (600 mg/day) or placebo capsules. Assessments included knee extension and flexion strength, handgrip strength, perceived muscle soreness, fatigue, and total quality recovery (TQR), measured at baseline, day 4, and day 8.ResultsAshwagandha significantly improved handgrip strength compared with placebo after 8 days (d = 0.33; p = 0.011), whereas no consistent effects were found for knee flexion or extension. Perceived soreness, fatigue, and recovery did not differ meaningfully between groups.ConclusionsShort-term Ashwagandha supplementation may enhance handgrip strength, suggesting a potential neuromuscular benefit in athletes. However, the lack of consistent effects on lower-limb strength and subjective recovery highlights the need for longer-term studies to confirm these findings. DOI: 10.1177/02601060261439102 PMID: 41940566

Toxicological Assessment of LN20188, a Botanical Combination of Withania somnifera Root and Abelmoschus esculentus Fruit Extracts.

7. Biomed Res Int. 2026;2026(1):e6355273. doi: 10.1155/bmri/6355273. Toxicological Assessment of LN20188, a Botanical Combination of Withania somnifera Root and Abelmoschus esculentus Fruit Extracts. Madireddy R(1), Dodda S(1), Chinta G(2), Alluri KV(1). Author information: (1)Department of Toxicology, Laila Nutra Private Limited, R&D Centre, Vijayawada, Andhra Pradesh, India. (2)Department of Pharmacology & Medical Affairs, Laila Nutra Private Limited, R&D Centre, Vijayawada, Andhra Pradesh, India. LN20188 is a botanical combination composed of extracts derived from Withania somnifera (L.) Dunal root and Abelmoschus esculentus (L.) Moench fruit. Our earlier investigations revealed the benefits of LN20188 in promoting gut motility and reducing constipation. The current investigation presents the toxicological profile of LN20188 following OECD guidelines for chemical testing. In an acute oral toxicity (AOT) study involving Sprague Dawley rats, no significant signs of toxicity or morbidity were observed, and the lethal dose (LD50) was determined to be greater than 2000 mg/kg body weight (b.w). Gross pathological findings further confirmed the safety of LN20188. In a repeated-dose subchronic toxicological investigation, rats were administered either 500, 1000, or 1500 mg/kg b.w of LN20188 for 90 consecutive days. LN20188 was found to be safe, where data on body weight, food consumption, organ weights, hematology, clinical biochemistry, and biomarkers were comparable to those of vehicle controls. The estimated no-observed-adverse-effect level (NOAEL) for LN20188 in male and female rats is determined to be 1500 mg/kg b.w. Genotoxicity studies, including bacterial reverse mutation, in vitrochromosomal aberration (CA), and in vivo micronucleus test (MNT) in mouse bone marrow erythrocytes, indicated no clastogenic or mutagenic activity. Results of the bacterial reverse mutation assay showed that LN20188 did not exhibit a notable increase in colony count (mutagenicity) up to 5000 μg/plate. In CA assay, LN20188 concentrations of up to 1000 μg/mL in the short term and 500 μg/mL in continuous exposure did not induce any chromosomal aberrations. Additionally, in vivo MNT showed that LN20188, up to 2000 mg/kg b.w, did not elevate the frequency of micronucleated PCEs (MNPCEs). Overall, these studies demonstrate that oral administration of LN20188 does not result in toxicity or genotoxic effects. Copyright © 2026 Ravikumar Madireddy et al. BioMed Research International published by John Wiley & Sons Ltd. DOI: 10.1155/bmri/6355273 PMID: 41914240 [Indexed for MEDLINE]

A clinical assessment of the therapeutic effects of Ashwagandha root extract on cognitive performance, sleep, and fatigue in children aged 6-12 years.

8. Front Nutr. 2026 Mar 11;13:1742138. doi: 10.3389/fnut.2026.1742138. eCollection 2026. A clinical assessment of the therapeutic effects of Ashwagandha root extract on cognitive performance, sleep, and fatigue in children aged 6-12 years. Saxena A(1), Lopresti A(2), Sharif M(1), Elon N(1), Suri R(3), Langade DK(3). Author information: (1)Department of Paediatric Medicine, D. Y. Patil University School of Medicine, Navi Mumbai, Maharashtra, India. (2)Clinical Research Australia, Duncraig, WA, Australia. (3)Department of Pharmacology, D. Y. Patil University School of Medicine, Navi Mumbai, Maharashtra, India. INTRODUCTION: Ashwagandha (Withania somnifera L.Dunal) is an adaptogenic herb known to reduce stress and enhance well-being in adults. METHODS: This randomized, double-blind, placebo controlled, parallel-group trial evaluated the efficacy and safety of standardized Ashwagandha root extract (ARE) in children with parent-reported concerns related to attention, concentration, or memory. Eight-five healthy children aged 6-12 years were randomized to receive ARE gummies (n = 42; 150 mg twice daily) or identical placebo gummies (n = 43) for 8 weeks. Primary outcomes included attention, memory, and executive function assessed using the Computerized Mental Performance Assessment System (COMPASS). Secondary outcomes included overall functioning and well-being assessed using the Strengths and Difficulties Questionnaire (SDQ), Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2 Parent version), Sleep Disturbance Scale for Children (SDSC), and Patient-Reported Outcomes Measurement Information System - Fatigue Scale. Safety was evaluated based on self-reported adverse events. RESULTS: Among 73 participants who completed the study (ARE, n = 39; placebo, n = 34), ARE supplementation significantly improved speed of information processing (p = 0.040). Improvements were also observed in delayed word recall (p = 0.038, d = 0.59), Stroop task accuracy (p = 0.021, d = 0.61), Corsi block span (p = 0.013, d = 0.66), and choice reaction time accuracy (p = 0.005, d = 0.75). Additionally, SDSC scores improved, indicating better parent-reported sleep quality (p = 0.035). No significant adverse events were reported. CONCLUSION: These findings suggest that an eight-week supplementation with ARE is well tolerated and may enhance cognitive performance and sleep quality in children. CLINICAL TRIAL REGISTRATION: The trial was prospectively registered with the Clinical Trials Registry of India (CTRI/2021/10/037126; dated 06/10/2021; CTRI) and the Australian and New Zealand Clinical Trials Registry (Reg. No.: ACTRN12621000656831; ANZCTR-Registration). Copyright © 2026 Saxena, Lopresti, Sharif, Elon, Suri and Langade. DOI: 10.3389/fnut.2026.1742138 PMCID: PMC13015348 PMID: 41889719 Conflict of interest statement: The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Efficacy and Safety of Low-Dose Ashwagandha Supplementation on Exercise Endurance: A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial.

9. Phytother Res. 2026 Mar 17. doi: 10.1002/ptr.70178. Online ahead of print. Efficacy and Safety of Low-Dose Ashwagandha Supplementation on Exercise Endurance: A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial. Prajapati H(1), Satia M(2), Shah D(2), Basera I(2), Shah T(2). Author information: (1)Prajna Health Care, Ahmedabad, India. (2)Ethicare Clinical Trial Services (OPC) Pvt. Ltd., Ahmedabad, India. Ashwagandha (Withania somnifera) is a well-known adaptogen with established roles in stress modulation and physical performance enhancement traditionally. Low dose Ashwagandha (LDA/Ashwa 0.30) is a bioactive-optimized root-only extract standardized to withanolides (> 15% w/w) and an ATP-active fraction (> 15% w/w). This study investigated the efficacy and safety of LDA supplementation on cardiorespiratory fitness and exercise-induced fatigue in healthy individuals. In this eight-week, randomized, double-blind, placebo-controlled study, healthy adults received either LDA (30 mg/day) or placebo. VO2max was assessed as primary endpoint using an indirect method via the Modified Bruce Protocol Treadmill Test (MBPTT). Secondary endpoints included lactic acid, creatine phosphokinase (CPK), Rating of Perceived Exertion (RPE), fatigue scores (VAS), and safety biomarkers. LDA significantly improved VO2max and maximal heart rate compared to the placebo. Participants in the treatment group showed lower lactic acid levels at exercise, indicating prolonged aerobic metabolism. CPK levels were significantly reduced, suggesting mitigation of muscle energy stress. Borg RPE and fatigue scores improved in the LDA group. LDA was well tolerated, with no treatment-related adverse events. Hematological, hepatic, renal, metabolic, and vital sign parameters remained within normal clinical ranges following intake of LDA. LDA supplementation for 8 weeks significantly enhanced cardiorespiratory fitness, delayed fatigue onset, and was safe for use in healthy adults. These findings support its potential as a safe and effective low-dose aid for endurance enhancement and overall exercise performance. © 2026 John Wiley & Sons Ltd. DOI: 10.1002/ptr.70178 PMID: 41846233

Withania adpressa Coss. ex Batt: A comprehensive review on its chemical composition, traditional uses, and biological activities.

10. Fitoterapia. 2026 Apr;190:107175. doi: 10.1016/j.fitote.2026.107175. Epub 2026 Mar 14. Withania adpressa Coss. ex Batt: A comprehensive review on its chemical composition, traditional uses, and biological activities. Ben-Bakrim W(1), El-Bouzidi L(2), Bekkouche K(2). Author information: (1)Cadi Ayyad University, Faculty of Sciences Semlalia, Laboratory of Excellence in Agrobiotechnology and Bioengineering, AgroBiotech Center, Labeled Research Unit-CNRST N°5, Plant Resources Protection and Valorization Team, 40000 Marrakech, Morocco. Electronic address: widadbenbakrim@gmail.com. (2)Cadi Ayyad University, Faculty of Sciences Semlalia, Laboratory of Excellence in Agrobiotechnology and Bioengineering, AgroBiotech Center, Labeled Research Unit-CNRST N°5, Plant Resources Protection and Valorization Team, 40000 Marrakech, Morocco. The plant kingdom is estimated to produce at least 250,000 distinct natural products, a significant proportion of which remain structurally and biologically uncharacterized, representing a vast, underexplored reservoir of chemical diversity. Withania adpressa Coss. ex Batt is an endemic species of the Moroccan Sahara and a member of the Solanaceae family. Traditionally, nearly all parts of the plant, including roots, leaves, flowers, and fruits have been used to treat digestive disorders, gastritis, colds, rheumatoid arthritis, and for their purported diuretic and aphrodisiac effects. The plant is notably rich in bioactive secondary metabolites, particularly withanolides, which are largely responsible for its diverse pharmacological properties, including antitumor, anticancer, antioxidant, antimicrobial, and anti-inflammatory activities. Despite promising findings supporting its anticancer potential, no W. adpressa based-extract has yet been developed into a commercially available traditional medicine. In this line, further studies and clinical trials are needed to confirm the plant's therapeutic potential and explore additional applications. This review consolidates, for the first time, current chemical, and biological research on W. adpressa, with a focus on its most bioactive extracts, fractions, and compounds, aiming to support their development into phytopharmaceutical development. Copyright © 2026 Elsevier B.V. All rights reserved. DOI: 10.1016/j.fitote.2026.107175 PMID: 41839296 [Indexed for MEDLINE] Conflict of interest statement: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this research article.

The Clinical Implications of Ashwagandha (Withania somnifera L.) with a Special Reference to Side Effects-A Review.

11. Nutrients. 2026 Mar 9;18(5):871. doi: 10.3390/nu18050871. The Clinical Implications of Ashwagandha (Withania somnifera L.) with a Special Reference to Side Effects-A Review. Winther K(1). Author information: (1)Department of Nutrition, Exercise and Sports, University of Copenhagen, 1958 Frederiksberg C, Denmark. Ashwagandha (Withania somnifera L.) root powder and extracts have long been used in Ayurvedic medicine to improve sleep and anxiety. Recent scientific investigations into its efficacy have shown promise for relief from anxiety, insomnia and stress and for improving the immune system. It has also been suggested that oxygen uptake in the cardiovascular system, muscle strength, cognitive function, the reproductive system and the aging process significantly benefit from ashwagandha treatment. Since the herbal remedy is taken daily by millions of people in India, China and parts of the West, it is interesting that there are very few case reports of side effects directly attributed to the treatment, suggesting that the administration of ashwagandha preparations may be safe. Currently, neither the European Medicines Agency nor the FDA considers ashwagandha as a drug or general health supplement. Therefore, ashwagandha products are marketed in the West as dietary supplements so that users may be exposed to unscrupulous vendors. In this narrative/literature review, scientific findings from basic research and human clinical trials on herbal remedies, spanning the period from 1994 to date, were critically evaluated for the purpose of highlighting knowledge gaps to provide context for new research. Such investigations will provide evidence for the efficacy and safety of ashwagandha treatment, thus making the herbal preparations more accessible to a wider audience. DOI: 10.3390/nu18050871 PMCID: PMC12986965 PMID: 41830041 [Indexed for MEDLINE] Conflict of interest statement: The author declares no conflicts of interest.

A proprietary herbal extract of ashwagandha root for stress and anxiety in healthy adults: a randomized, double-blind, three-arm, placebo-controlled efficacy and safety study.

12. J Med Life. 2026 Jan;19(1):49-62. doi: 10.25122/jml-2025-0172. A proprietary herbal extract of ashwagandha root for stress and anxiety in healthy adults: a randomized, double-blind, three-arm, placebo-controlled efficacy and safety study. West RE(1), Biswas A(2), Rao R(3), Tayade H(4), Ademola J(5). Author information: (1)Neuroscience, Northwest Neuro Professionals, LLC, Seattle, United States of America. (2)Obstetrics and gynaecology, Clini-Ton-Multi-Speciality Clinic, Jaipur, India. (3)Dentistry, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Navi Mumbai, India. (4)Pharmcology, D Y Patil University School of Medicine, Pune, India. (5)Clinical Research, San Francisco Research Institute, San Francisco , United States of America. Stress and anxiety are interconnected, sharing both behavioural and neural foundations. Ashwagandha (Withania somnifera) helps reduce stress and anxiety. This study aimed to evaluate the efficacy and safety of a proprietary herbal extract of ashwagandha root (APB) in adult men and women with moderate stress and anxiety. This 8-week, randomized, double-blind, three-arm, placebo-controlled trial included 141 healthy men and women aged 18-65 years with stress and anxiety. Participants were randomized to receive either 300 mg of APB twice daily (n = 47), ashwagandha root extract (ARE, n = 47), or placebo (PL, n = 47) for 8 weeks. The primary endpoint was a change in serum cortisol levels at week 8. Secondary endpoints were the mean changes in Perceived Stress Scale (PSS), Hamilton Anxiety Rating Scale (HAM-A), Profile of Mood States (POMS), and Oxford Happiness Questionnaire (OHQ) scores. Safety was assessed through clinical adverse events (AEs) and laboratory parameters. Between-group comparisons were analyzed using one-way ANOVA with Tukey's post-hoc test, and within-group changes were assessed using paired t-tests. At 8 weeks, all groups have shown a significant reduction in serum cortisol, and improvements in PSS (P < 0.0001), HAM-A (P = 0.001), and POMS domain scores (tension, depression, and anger, P < 0.0001). In addition, the APB showed significant differences compared with ARE and PL for PSS, HAM-A total score, OHQ, and POMS (P < 0.05). The proprietary herbal extract of ashwagandha root (300mg twice daily) is considered an effective and safe intervention for reducing stress and anxiety. © 2026 The Author(s). DOI: 10.25122/jml-2025-0172 PMCID: PMC12973907 PMID: 41815853 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflict of interest.

Assessing Digestive Transformations of Withania somnifera Extracts via LC-MS/MS Profiling with a Focus on Bioactive Compounds Withaferin A, Withanolide A, Withanoside IV, and Untargeted Metabolomics.

13. J Agric Food Chem. 2026 Mar 18;74(10):8851-8863. doi: 10.1021/acs.jafc.5c09897. Epub 2026 Mar 5. Assessing Digestive Transformations of Withania somnifera Extracts via LC-MS/MS Profiling with a Focus on Bioactive Compounds Withaferin A, Withanolide A, Withanoside IV, and Untargeted Metabolomics. Barr SA(1), Davis LJ(1), Vidar W(2), Williamson RT(1), Strangman WK(1). Author information: (1)Department of Chemistry and Biochemistry, University of North Carolina Wilmington, 601 S. College Road, Wilmington, North Carolina 28403, United States. (2)Triad Mass Spectrometry Center, Department of Chemistry and Biochemistry, University of North Carolina Greensboro, 1400 Spring Garden Street, Greensboro, North Carolina 27412, United States. Botanical extracts are widely employed as health care agents but lack the rigorous vetting required for FDA-approved pharmaceuticals. Research on phytochemical bioavailability and transformation has mainly focused on liver metabolism and plasma binding, while gastrointestinal and microbiome metabolism studies remain limited. This study combined digestive in vitro assays with mass spectrometry-based metabolomics and molecular networking to analyze metabolites in Withania somnifera leaf and root extracts, along with three known bioactive reference standards: withaferin A, withanolide A, and withanoside IV. Both withaferin A and withanoside IV underwent significant in vitro transformation, while withanolide A remained stable across conditions. Molecular networking revealed that withanolides in the root extract were largely stable, whereas many in the leaf extract were more labile under the assay conditions. Detailed network analysis also enabled the identification of specific metabolite transformations. These findings support the refinement of in vitro models to better predict in vivo behavior in complex botanical mixtures. DOI: 10.1021/acs.jafc.5c09897 PMID: 41784222 [Indexed for MEDLINE]

Efficacy and safety of Ashwagandha (Withania somnifera) root extract in pregnant women: a prospective, randomized, comparative, open-label, 12-week study.

14. Front Glob Womens Health. 2026 Feb 12;7:1767865. doi: 10.3389/fgwh.2026.1767865. eCollection 2026. Efficacy and safety of Ashwagandha (Withania somnifera) root extract in pregnant women: a prospective, randomized, comparative, open-label, 12-week study. Ajgaonkar A(1), Tayade H(2), Nayak A(3). Author information: (1)Department of Obstetrics & Gynaecology Division, Trupti Hospital, Thane West, Maharashtra, India. (2)Department of Pharmacology, D Y Patil University School of Medicine, Pune, Maharashtra, India. (3)Department of Pharmacology, D Y Patil University School of Medicine, Navi Mumbai, Maharashtra, India. INTRODUCTION: Pregnancy is associated with increased risk of anemia, high psychological stress, and sleep disturbances, yet safe therapeutic options remain limited. Ashwagandha (Withania somnifera) root extract (ARE) possesses adaptogenic and hematopoietic potential, but evidence in pregnant women is scarce. The aim of the current study is to evaluate the efficacy and safety of ARE on hematological parameters and on stress, sleep quality, and laboratory safety markers in pregnant women. METHODS: This 12-week, prospective, randomized, open-label, comparative trial enrolled 70 pregnant women in the second trimester. Participants received either ARE 300 mg twice daily plus standard hematinic therapy or standard hematinic therapy (standard of care; SOC) alone. Primary endpoints included changes in hemoglobin (Hb) and red blood cell (RBC) indices. Secondary endpoints included perceived stress, sleep quality, and safety assessments (adverse events, liver, renal, cardiac, and thyroid markers). Efficacy was analyzed in the per-protocol population; safety in the intention-to-treat population. RESULTS: Of 70 randomized participants, 63 completed the study (ARE: n = 32; SOC: n = 31). ARE supplementation produced significant improvements in hematological parameters: Hb increased by 1.06 ± 0.44 g/dL vs. 0.78 ± 0.24 g/dL with SOC (between-group difference 0.28 g/dL; p = 0.003), mean corpuscular hemoglobin concentration improved significantly (difference 0.73 g/dL; p = 0.017), and red cell distribution width decreased markedly (difference -0.57%; p < 0.001). RBC count and hematocrit showed favorable but non-significant trends. ARE significantly reduced perceived stress at Week 12 (-10.50 vs. -5.35; p < 0.001) and improved key sleep parameters, including subjective sleep quality at all visits (p = 0.036), sleep duration (Week 8 and 12; p < 0.001), and sleep disturbances (Week 12; p = 0.028). No adverse events or serious adverse events occurred. Laboratory evaluations showed no detrimental effects on hepatic, renal, or thyroid function. DISCUSSION: ARE supplementation for 12 weeks improved hemoglobin levels, RBC quality, perceived stress, and multiple aspects of sleep in pregnant women, with no adverse events and stable organ-function markers. ARE appears to be a tolerable and suitable adjunct to standard prenatal care for supporting hematological and psychological well-being during pregnancy. CLINICAL TRIAL REGISTRATION: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTIyNjQ2&Enc=&userName=, identifier CTRI/2025/01/079238 on January 22, 2025. © 2026 Ajgaonkar, Tayade and Nayak. DOI: 10.3389/fgwh.2026.1767865 PMCID: PMC12936510 PMID: 41767760 Conflict of interest statement: The standardized Ashwagandha root extract (KSM-66) was supplied by Ixoreal Biomed Inc. The supplier had no role in study design, participant recruitment, data collection, statistical analysis, interpretation of results, or manuscript preparation. All analyses and interpretations were conducted independently by the investigators. The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Efficacy and safety of ashwagandha root extract on sexual health in healthy Men: a prospective, randomized, double-blind, placebo-controlled study.

15. Front Reprod Health. 2026 Feb 12;8:1774098. doi: 10.3389/frph.2026.1774098. eCollection 2026. Efficacy and safety of ashwagandha root extract on sexual health in healthy Men: a prospective, randomized, double-blind, placebo-controlled study. Khanna A(1), Khanna M(1), Panchal P(2). Author information: (1)Department of Internal Medicine, Aman Hospital and Research Center, Vadodara, Gujarat, India. (2)Department of Clinical Research, Aman Hospital and Research Center, Vadodara, Gujarat, India. INTRODUCTION: Ashwagandha (Withania somnifera) is widely recognized in Ayurvedic medicine as a potent Rasayana and aphrodisiac herb, with preclinical studies demonstrating androgen-modulating, anxiolytic, and antioxidant properties that may enhance male reproductive physiology. The present study aimed to rigorously evaluate the efficacy and safety of a standardized Ashwagandha Root Extract (ARE) in improving sexual function in healthy adult men. METHODS: A prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted over 8 weeks in 76 healthy males aged 30-50 years. Participants were randomized (1:1) to receive either 300 mg ARE twice daily or a matched placebo. Sexual functioning was evaluated using validated instruments, including the Sexual Desire Inventory-2 (SDI-2), number of Satisfying Sexual Events (SSEs), and the International Index of Erectile Function (IIEF). Semen parameters were analyzed using WHO-standardized procedures, and quality of life was assessed with the Short Form-12 Health Survey. Both intention-to-treat and safety analyses were performed with a significance threshold of α = 0.05. RESULTS: ARE supplementation resulted in statistically significant improvements across multiple domains of sexual function compared with placebo, including SDI-2 scores, SSEs, sexual desire, and overall IIEF outcomes (p ≤ 0.001). Semen analysis demonstrated a 36% increase in ejaculate volume, 38% improvement in total sperm count, and an 87% increase in total sperm motility after 8 weeks, with moderate to large effect sizes indicating clinically meaningful benefits. No adverse events or safety concerns were reported. DISCUSSION: These findings suggest that standardized ARE may serve as an effective and well-tolerated natural intervention to support male sexual health. CLINICAL TRIAL REGISTRATION: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzY3ODE=&Enc=&userName=, identifier CTRI/2,022/11/047,501. © 2026 Khanna, Khanna and Panchal. DOI: 10.3389/frph.2026.1774098 PMCID: PMC12935928 PMID: 41766918 Conflict of interest statement: The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Characterization of phytoconstituents of vital herbal oils by GC-MS and LC-MS/MS and their bioactivities.

16. J Food Sci Technol. 2026 Feb;63(2):238-250. doi: 10.1007/s13197-024-06148-0. Epub 2024 Dec 7. Characterization of phytoconstituents of vital herbal oils by GC-MS and LC-MS/MS and their bioactivities. Gopalakrishnan AV(1), Singh PK(1), Krishnan N(1), Devadasan V(1), Gopinath SCB(2)(3)(4), Raman P(1). Author information: (1)Department of Biotechnology, School of Bioengineering, Faculty of Engineering and Technology, SRM Institute of Science and Technology, Kattankulathur 603 203, Chengalpet - Dt, Tamil Nadu India. (2)Center for Global Health Research, Saveetha Medical College & Hospital, Saveetha Institute of Medical and Technical Sciences (SIMATS), Thandalam, Chennai, Tamil Nadu 602 105 India. (3)Faculty of Chemical Engineering & Technology, Universiti Malaysia Perlis (UniMAP), 02600 Arau, Perlis, Malaysia. (4)Institute of Nano Electronic Engineering, Universiti Malaysia Perlis (UniMAP), 01000 Kangar, Perlis, Malaysia. The ancient Indian Siddha medicine system, practiced for thousands of years, is now receiving widespread recognition globally. "Siddha" system of medicine is one among the Indian traditional system of medicine that has its roots in Tamil culture. This study seeks to explore and document the diverse practices and medicinal remedies employed by Siddha practitioners. The Siddha formulations include oil-medicated herbal products and thailam, an oil formulation that contains drugs and raw extracts. Kuzhithailam is a specially prepared oil in the Siddha system by a destructive distillation process called the pudam process. Amukkara (Withania somnifera) and neem (Azadirachta indica) Kuzhithailams are two among the formulations. Neem, a popular herb for skin infections and general health because of its antibacterial, anti-inflammatory, and blood-purifying properties. Amukkara plant kizhangu helps mental health, boosts energy, and maintains hormonal balance. The current study investigates the metabolites of amukkara (AMKT) and neem Kuzhithailams (NMKT) by GC-MS and LC-MS/MS. Mass spectrometric analysis of AMKT and NMKT revealed the presence of metabolites belonging to different groups, including saturated and unsaturated fatty acids, phenolics, vitamins, terpenoids, and sterols. The alkaloid compounds, including withasomnine, pseudopelletierine, hygroline, and tigloidine, were detected in AMKT. Gedunin, nimbolide, 6-desacetylnimbin, 28-deoxonimbolide, azadiradione, nimbin, salannin, 2-monomyrsitin, and salannol were detected in NMKT. The Kuzhithailams possessed antioxidant activities, NMKT was observed to has a higher antioxidant capacity than AMKT. The bioactive compounds of neem Kuzhithailam have moieties like hydroxyl, ketone, conjugated double bonds, lactone etc. which stabilize the free radicals and contribute to higher antioxidant properties of NMKT compared to AMKT. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13197-024-06148-0. © Association of Food Scientists & Technologists (India) 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. DOI: 10.1007/s13197-024-06148-0 PMCID: PMC12926267 PMID: 41737715 Conflict of interest statement: Conflicts of interestNone.

Ashwagandha (Withania somnifera) Root Extract Improves General Health in Elderly Men and Women: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study.

17. Phytother Res. 2026 Feb 22. doi: 10.1002/ptr.70125. Online ahead of print. Ashwagandha (Withania somnifera) Root Extract Improves General Health in Elderly Men and Women: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study. Honnutagi R(1), Ingale A(2), Naikawdi A(3). Author information: (1)Department of General Medicine, Shri B. M. Patil Medical College Vijayapura, Vijayapura, Karnataka, India. (2)Department of Pharmacology, S. Nijalingappa Medical College, Bagalkote, Karnataka, India. (3)Department of Pharmacology, Shri B. M. Patil Medical College, Vijayapura, Karnataka, India. Ashwagandha (Withania somnifera), an adaptogen, is widely used in traditional Indian medicine for its health benefits in elderly people with functional limitations and physical disabilities. This double-blind, randomized, placebo-controlled clinical trial study assessed the efficacy and safety of a standardized Ashwagandha Root Extract (ARE) on general health improvement in elderly. Fifty (32 male, 18 female) healthy people aged between 60 and 85 years who consented to participate were randomly assigned to receive either capsule ARE 300 mg twice daily orally (n = 25) or an identical placebo (n = 21) for 8 weeks. The primary efficacy outcome was change in scores for Older People's Quality of Life (OPQOL) questionnaire, whereas secondary outcomes were change in scores for the Epworth Sleepiness Scale (ESS), and Senior Fitness Test (SFT). Clinical safety was evaluated using adverse events and global assessment of tolerability to therapy (GATT) by the physician. Greater improvement in OPQOL scores was observed with ARE, compared to placebo at both week 4 (p = 0.023) and week 8 (p < 0.0001), and these differences were observed in all sub-scales of OPQOL. Patients receiving ARE showed higher improvements after week 8 for total scores for ESS (p < 0.001), and SFT sub-scales (p < 0.01). The majority of participants on ARE reported excellent to good tolerability (96.0%). No adverse events were reported in the ARE group, while one patient reported nausea and headache in the placebo group. Ashwagandha root extract can be a useful herbal intervention for the improvement of general health and quality of life in elderly men and women. © 2026 John Wiley & Sons Ltd. DOI: 10.1002/ptr.70125 PMID: 41725116

Effects of Shatavari (Asparagus racemosus) Root Extract on Sexual Wellness in Women: Findings from a Prospective, Randomized, Double-Blind, Three-Arm, Parallel-Group, Placebo-Controlled Study.

18. Int J Womens Health. 2026 Feb 10;18:561213. doi: 10.2147/IJWH.S561213. eCollection 2026. Effects of Shatavari (Asparagus racemosus) Root Extract on Sexual Wellness in Women: Findings from a Prospective, Randomized, Double-Blind, Three-Arm, Parallel-Group, Placebo-Controlled Study. Ademola J(1), Mahajan S(2), Srivathsan M(3), Langade D(3). Author information: (1)Department of Clinical Research, San Francisco Research Institute, San Francisco, CA, 94127, USA. (2)Department of Gynecology and Obstetrics, Tieten Medi City Hospital, Thane, Maharashtra, 400610, India. (3)Department of Pharmacology, D Y Patil University of School and Medicine, Navi Mumbai, Maharashtra, 400706, India. PURPOSE: Women's sexual health is affected by physical, psychological, and emotional aspects. In Ayurvedic medicine, Shatavari (Asparagus racemosus) is traditionally classified as a Rasayana known to promote reproductive health and overall well-being in women. The present study aims to evaluate the safety and efficacy of a standardized Shatavari root extract (SHT) in improving women's sexual health. PATIENTS AND METHODS: A prospective, randomized, double-blinded, placebo-controlled, three-armed study was conducted over 8 weeks with 135 women participants. Participants were randomly assigned to receive either SHT, Shatavari with Ashwagandha root extracts (SHT-ARE), or a placebo (PL). The primary outcome was assessed using the Female Sexual Function Index (FSFI). Secondary outcomes were measured by Satisfying Sexual Events (SSEs), Female Sexual Distress Scale (FSDS), Profile of Mood States (POMS), Oxford Happiness Questionnaire (OHQ), and Pittsburgh Sleep Quality Index (PSQI), which were used for efficacy analysis. The safety parameters were monitored by treatment-emergent adverse events and changes in liver, thyroid, and renal function markers. RESULTS: At post-intervention (8 weeks), the SHT-ARE group demonstrated improvements in FSFI Arousal (P = 0.041), Lubrication (P = 0.027), Orgasm (P = 0.031), and Total FSFI (P = 0.005) scores compared to the PL group, whereas the SHT group showed improvements in only Total FSFI (P = 0.025) and Satisfaction (P < 0.0001). The number of sexual intercourses between SHT-ARE and PL was increased significantly (P = 0.001), while FSDS scores showed a significant difference in both SHT-ARE (P < 0.0001) and SHT (P = 0.008) when compared to the PL group. Improved OHQ scores in the SHT-ARE group (P < 0.0001) signify greater happiness. Reduced POMS values (SHT-ARE) specified reductions in Tension, Anger, Depression, Fatigue, Esteem-related affect, Confusion, and Total score (P < 0.0001) compared to PL. The SHT-ARE group at week 8 represented no significant differences in PSQI scores, except for Sleep efficiency (P = 0.045) compared to PL. All reported events were mild and resolved with no intervention. CONCLUSION: Shatavari root extract is considered a safe, effective, and well-tolerated treatment for improving women's sexual health and well-being. In addition, it shows an additive effect in combination with Ashwagandha. © 2026 Ademola et al. DOI: 10.2147/IJWH.S561213 PMCID: PMC12912092 PMID: 41710148 Conflict of interest statement: The authors report no conflicts of interest in this work.

Efficacy and safety of Ashwagandha (Withania somnifera) root extract on stress and weight management in adults: a prospective, randomized, double-blind, placebo-controlled study.

19. J Med Life. 2025 Dec;18(12):1140-1154. doi: 10.25122/jml-2025-0147. Efficacy and safety of Ashwagandha (Withania somnifera) root extract on stress and weight management in adults: a prospective, randomized, double-blind, placebo-controlled study. Pakhale K(1), Pakhale R(2), Srivathsan M(3), Langade J(2), Langade D(3). Author information: (1)Metabolic Syndrome, Metabol-Lifestyle Clinic for Metabolic Syndrome, Mumbai, Maharashtra, India. (2)Clinical Research, Clinsearch Healthcare Solutions, Thane, Maharashtra, India. (3)Pharmacology, D Y Patil University School of Medicine, Nerul, Navi Mumbai, Maharashtra, India. The relationship between excess body weight and stress significantly impacts overall health. The current study evaluated the efficacy and safety of Ashwagandha (Withania somnifera) root extract (ARE) in altering stress biomarkers and its role in weight management. In this prospective, randomized, double-blind, placebo-controlled study, 100 participants (age: 19-65 years) were randomized to receive either ARE 300 mg twice daily (n = 50) or an identical placebo (PL, n = 50) for 24 weeks. The primary efficacy endpoints were changes in body weight and body mass index (BMI). Secondary endpoints included evaluation of stress (Perceived Stress Scale, PSS), quality of life (Short Form-12 Quality of Life Scale), subjective satisfaction (Subjective Satisfaction Scale, SSS), and food cravings (Food Cravings Questionnaire-Trait, FCQ-T). Clinical safety was assessed based on treatment-emergent adverse events (TEAEs) and laboratory parameters, including complete blood count, renal function tests, liver function tests, lipid profile, thyroid function tests, and glycemic parameters (plasma glucose and glycated hemoglobin). Efficacy was analyzed in 91 patients. ARE administration resulted in a significant reduction in body weight (-8.46 ± 3.86 kg; P < 0.0001) and BMI (-3.31 ± 1.57 kg/m2; P < 0.0001) compared to the PL (-2.41 ± 2.07 kg and -0.93 ± 0.79 kg/m2 for body weight and BMI, respectively). Compared with PL, ARE showed significant improvements (P < 0.05) in PSS, SF-12, SSS, and FCQ-T scores. A total of seven participants with ARE and six with PL reported mild adverse events (nausea, abdominal pain, and drowsiness), which were resolved without any intervention. Ashwagandha root extract may offer a safe and beneficial approach for stress reduction and weight management. © 2025 The Author(s). DOI: 10.25122/jml-2025-0147 PMCID: PMC12863098 PMID: 41635453 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflict of interest.

Effects of ashwagandha supplementation on athletic performance and recovery: A narrative review.

20. Nutr Health. 2026 May 2:2601060261447118. doi: 10.1177/02601060261447118. Online ahead of print. Effects of ashwagandha supplementation on athletic performance and recovery: A narrative review. AKbulut B(1), Canbolat E(2). Author information: (1)Department of Nutrition and Dietetics, Institute of Health Sciences, Ankara University, Ankara, Turkey. (2)Faculty of Health Sciences, Department of Nutrition and Dietetics, Ankara University, Ankara, Turkey. Background: Ashwagandha, a plant belonging to the Solanaceae family, has gained increasing attention in recent years due to its antioxidant, anti-inflammatory, and adaptogenic properties, and its potential to improve physical performance and support post-exercise recovery. Objectives: This narrative review aims to summarize and critically evaluate the current scientific evidence regarding the effects of Ashwagandha supplementation on exercise-induced oxidative stress, athletic performance, and safety. Methodology: This study is a narrative review based on previously published literature. The synthesis involved evaluating current studies focusing primarily on Ashwagandha supplementation and its relationship to exercise and sports performance. The included sources comprise clinical trials, meta-analyses, and review articles reporting outcomes related to strength, endurance, recovery, and safety. Results: Studies suggest that Ashwagandha dosages of 330-1000 mg daily will increase endurance and facilitate quicker recoveries, with a twice daily dose of 300 mg in combination with weight training increasing muscular strength and hypertrophy. Ashwagandha is also believed to regulate cortisol levels and relieve anxiety and insomnia. Typical dosage levels in the sporting field appear to be higher, at approximately 600 mg/day, but a lower dose will be required by less active people. Side effects are mild in the majority of the literature and no dangerous side effects occur at recommended dosages. Conclusion: Ashwagandha has been found to be safe and effective in a natural supplementary capacity in sports and athletics. The correct dosage and application period of Ashwagandha should be taken into consideration to reap its properties in the human body. DOI: 10.1177/02601060261447118 PMID: 42068281

Effectiveness of Ayurvedic Nutritional Supplements and Yoga Protocol in Reducing the Incidence and Severity of Acute Mountain Sickness (AYAMS Study): Study Protocol for an Open-Label Randomized Controlled Trial.

21. JMIR Res Protoc. 2026 Apr 8;15:e81567. doi: 10.2196/81567. Effectiveness of Ayurvedic Nutritional Supplements and Yoga Protocol in Reducing the Incidence and Severity of Acute Mountain Sickness (AYAMS Study): Study Protocol for an Open-Label Randomized Controlled Trial. Rai AK(1), Jameela S(2), Yadav AK(3), Joshi RK(3), Mundada P(2), Ahmad A(2), Mahajon B(4), Sharma BS(2), Khanduri S(2), Yadav B(2), Tripathi A(2), Rana RK(2), Chandrasekhararao B(2), Srikanth N(2), Rao R(5), Acharya R(2). Author information: (1)Ayurvedic and Unani Tibbia College and Hospital, New Delhi, India. (2)Central Council for Research in Ayurvedic Sciences, New Delhi, India. (3)Office of the DGAFMS, Fifth Floor, Block A, Defence Officer Complex, Africa Avenue, New Delhi, 110023, India, 91 9868815430. (4)All India Institute of Ayurveda, New Delhi, India. (5)Central Council for Research in Yoga and Naturopathy, New Delhi, India. BACKGROUND: Acute mountain sickness (AMS) poses a unique and formidable challenge to healthy personnel at high altitudes. OBJECTIVE: This randomized controlled trial (RCT) protocol aimed to assess the effectiveness of Ayurvedic nutritional supplements in conjunction with a yoga protocol in reducing the incidence and severity of AMS among healthy personnel stationed in the challenging high-altitude landscapes of the western Himalayas. METHODS: The proposed open-label, parallel-group RCT was conducted in apparently healthy individuals of any gender aged 18-50 years. The study was conducted at two distinct high-altitude stages within the western Himalayan region: stage I, situated at an elevation ranging from 9000 to 12,000 feet and stage II, spanning 12,000 to 15,000 feet. A total of 1660 participants (n=830 per stage) underwent random assignment in a 1:1 ratio to receive either the existing acclimatization schedule (AS) for high altitude (control group) or the Ayush intervention (Ayush group) in addition to the AS. The participants in the Ayush group received Ayurvedic nutritional supplements, including the Ayur-nutri kit (Ayush poshak yoga, 25 g, and Ayush cardiac care tea, 125 mL), twice daily, along with a yoga protocol (60 min daily) for 120 days. The primary outcome was the incidence of AMS, assessed using the 2018 Lake Louise Scoring System, and the proportion of participants with a Lake Louise Scoring System score of 6 or higher during the first 7 days from baseline. The secondary outcome measures included the proportion of participants with thromboembolic events; changes in coagulation and hemostasis activation markers and proinflammatory markers; and changes in self-reported negative emotional states (depression, anxiety, and stress), sleep quality, and overall quality of life (assessed through Depression Anxiety Stress Scale-21 items, Pittsburgh Sleep Quality Index, and 12-item short-form, respectively) on day 60 and day 120 from baseline. RESULTS: The study was funded in March 2023. The data collection was completed in December 2023. A total of 1660 participants were enrolled in the study. The analysis of the study data is in progress. The study outcomes are expected to be published by December 2026. CONCLUSIONS: This RCT was the first of its kind to explore the potential benefits of using Ayurvedic nutritional supplements and a yoga protocol in conjunction with the standard AS to reduce the occurrence and severity of AMS among healthy personnel. The outcomes of this trial can aid in better acclimatization and resilience among healthy personnel at high altitudes. © Amit Kumar Rai, Sophia Jameela, Arun Kumar Yadav, Rajneesh Kumar Joshi, Pallavi Mundada, Azeem Ahmad, Bidhan Mahajon, Bhagwan Sahai Sharma, Shruti Khanduri, Babita Yadav, Arunabh Tripathi, Rakesh Kumar Rana, Bhogavalli Chandrasekhararao, Narayanam Srikanth, Raghavendra Rao, Rabinarayan Acharya. Originally published in JMIR Research Protocols (https://www.researchprotocols.org). DOI: 10.2196/81567 PMCID: PMC13061369 PMID: 41950501 [Indexed for MEDLINE] Conflict of interest statement: Conflicts of Interest: The authors declare that they have no known competing interests. However, the study protocol, data collection procedures, and analytical framework were jointly developed by the funding agency, CCRAS, and collaborators following internal scientific and ethical review processes. Although CCRAS supported the study infrastructure and data management, the investigators retained full academic independence in interpreting the study findings.

Exploring Phytoleads and Traditional Herbal Therapies: A Comparative Review on Stress Management.

22. Curr Pharm Des. 2026 Mar 27. doi: 10.2174/0113816128429468260218054442. Online ahead of print. Exploring Phytoleads and Traditional Herbal Therapies: A Comparative Review on Stress Management. Rathee S(1), Sahu A(1), Soni S(1), Sen D(1), Jain SK(1). Author information: (1)Department of Pharmaceutical Sciences, Dr. Harisingh Gour Vishwavidyalaya (A Central University), Sagar, Madhya Pradesh, 470003, India. This review offers a thorough examination of stress and the therapeutic use of herbal medicine. Recognizing the ubiquity of stress in modern life, this review discusses the biological mechanisms of stress, especially at the molecular level, where the presence of phenylpropanoid derivatives has a major regulatory effect. Plant-derived compounds, especially phenylpropanoids, tetracyclic triterpenoids, and lignans, are discussed for their potential use in stress management. Recent clinical trial data confirm the efficacy of these plant-derived compounds in the management of stress symptoms, such as the reduction of anxiety, improvement in mood stability, modulation of cortisol levels, improvement in sleep patterns, and enhancement of mental well-being. Of particular interest is the use of adaptogenic herbs such as Withania somnifera (ashwagandha), which has shown consistent efficacy in enhancing stress resilience and improving quality of life. This review seeks to inform researchers and practitioners of the growing importance of herbal medicine in the management of stress-related health issues. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net. DOI: 10.2174/0113816128429468260218054442 PMID: 41919431

Clinical evidence for the adaptogenic effects of Withania somnifera and Rhodiola rosea - A systematic review with molecular interpretation of psychometric outcomes.

23. Ann Agric Environ Med. 2026 Mar 25;33(1):3-11. doi: 10.26444/aaem/213417. Epub 2025 Dec 9. Clinical evidence for the adaptogenic effects of Withania somnifera and Rhodiola rosea - A systematic review with molecular interpretation of psychometric outcomes. Łuszczak J(1), Kocki J(2). Author information: (1)Department of Biology with Genetics, Medical University, Lublin, Poland. (2)Department of Clinical Genetics, Medical University, Lublin, Poland. INTRODUCTION AND OBJECTIVE: Adaptogens are plant-derived substances that enhance the body's resilience to physical and psychological stress, with Withania somnifera and Rhodiola rosea being among the most studied representatives. The aim of this review is to evaluate the adaptogenic effects of W. somnifera and R. rosea based on randomized controlled trials (RCTs). REVIEW METHODS: A systematic literature search was performed using the key words: 'ashwagandha', 'Withania somnifera', 'Rhodiola rosea', and 'plant adaptogen'. Twenty-four studies met the inclusion criteria - 19 on W. somnifera and 5 on R. rosea. BRIEF DESCRIPTION OF THE STATE OF KNOWLEDGE: The analyzed trials involved 10-590 participants, aged 18-75 years, both healthy individuals and patients with stress-related or functional disorders. Interventions included standardized extracts at daily doses of 120-1000 mg for W. somnifera and 290-1500 mg for R. rosea, with supplementation lasting 3-16 weeks. Reported benefits included reduction of stress and anxiety, alleviation of depressive symptoms, improved sleep quality, enhancement of cognitive functions, increased muscle strength and recovery, and favourable hormonal changes. Methodological heterogeneity, short intervention periods, and small sample sizes remain limitations. SUMMARY: Evidence from RCTs confirms that W. somnifera and R. rosea exert multi-dimensional adaptogenic effects, improving psychophysical health and supporting stress resilience. Their mechanisms involve regulation of the hypothalamic-pituitary-adrenal axis, neurotransmission, immune and hormonal pathways. Further long-term, high-quality clinical trials, supplemented with molecular and systemic approaches, are required to consolidate their role in integrative, evidence-based medicine. DOI: 10.26444/aaem/213417 PMID: 41906501 [Indexed for MEDLINE]

Efficacy and Safety of Herbal Supplements with Anxiolytic, Antidepressant, and Sedative Action: A Review of Clinical Data and Toxicological Risks.

24. Pharmaceuticals (Basel). 2026 Feb 28;19(3):399. doi: 10.3390/ph19030399. Efficacy and Safety of Herbal Supplements with Anxiolytic, Antidepressant, and Sedative Action: A Review of Clinical Data and Toxicological Risks. Căuș MN(1), Lupoae M(1), Chițescu CL(1). Author information: (1)Research Centre in the Medical-Pharmaceutical Field, Faculty of Medicine and Pharmacy, "Dunarea de Jos" University, 800201 Galati, Romania. Background/Objectives: Plant-based supplements are widely used for the management of anxiety, depression, and insomnia. Despite their over-the-counter availability and perceived safety, these products may pose relevant pharmacological and toxicological risks. This narrative review critically evaluates clinical evidence on commonly used herbal preparations, with particular emphasis on herb-drug interactions, adverse effects, and issues related to product adulteration. Methods: Major scientific databases (PubMed, Scopus, and Web of Science) were searched to identify clinical studies evaluating plant-based supplements for mental health and sleep disorders. Data on study design, dosage, efficacy, and adverse events were analyzed, together with regulatory information and reports of product adulteration and quality concerns. Results: Herbal supplements such as Hypericum perforatum, Passiflora incarnata, Valeriana officinalis, Piper methysticum, Withania somnifera, Crocus sativus, and Curcuma longa demonstrated anxiolytic, antidepressant, and sedative effects in clinical studies, with improvements in mood, stress levels, and sleep quality. Proposed mechanisms include modulation of monoaminergic and GABAergic pathways, serotonergic activity, regulation of the hypothalamic-pituitary-adrenal axis, and anti-inflammatory effects. However, clinically relevant risks were identified, including cytochrome P450-mediated drug interactions, excessive sedation, serotonin syndrome, and toxic effects associated with adulterated products, such as hepatotoxicity, cardiovascular events, and neurological disturbances. Conclusions: While plant-based supplements may provide clinically meaningful benefits for anxiety, depression, and insomnia, their use requires careful clinical monitoring due to potential pharmacokinetic and pharmacodynamic interactions and safety concerns. Increased awareness of herb-drug interactions and stricter quality control are essential to optimize therapeutic outcomes and minimize harm. DOI: 10.3390/ph19030399 PMCID: PMC13028908 PMID: 41901246 Conflict of interest statement: The authors declare no conflicts of interest.

System-Level, Molecular and Cellular Mechanisms of Selected Plant Adaptogens-A Review.

25. Nutrients. 2026 Mar 16;18(6):931. doi: 10.3390/nu18060931. System-Level, Molecular and Cellular Mechanisms of Selected Plant Adaptogens-A Review. Such S(1), Puchalski C(1), Kogut Ł(1), Zaguła G(1). Author information: (1)Department of Bioenergetics, Food Analysis and Microbiology, Institute of Food Technology and Nutrition, Faculty of Technology and Life Science, University of Rzeszów, Aleja Rejtana 16C, 35-959 Rzeszow, Poland. Background/Objectives: Adaptogens are plant-derived substances that enhance the body's nonspecific resistance to physical, chemical, biological, and psychological stressors by normalizing physiological functions. This article discusses the molecular mechanisms of action of seven key plant adaptogens-Rhodiola rosea, Schisandra chinensis, Withania somnifera, Eleutherococcus senticosus, Panax ginseng, Ocimum tenuiflorum, and Bacopa monnieri-in the context of chronic stress and lifestyle-related diseases. Methods: A review of the scientific literature is performed, including preclinical in vitro and in vivo studies, randomized placebo-controlled clinical trials, and studies employing network pharmacology analyses, molecular docking, and genomic techniques such as gene expression profiling. The interactions of active constituents with signaling pathways, molecular targets, and synergistic mechanisms were analyzed based on publications from the years 2010-2025. Results: Adaptogens exhibit pleiotropic activity: they regulate the HPA axis (Hypothalamic-Pituitary-Adrenal axis); induce Hsp70/Hsp16 expression; modulate SAPK/JNK, FOXO, and NF-κB pathways; and demonstrate antioxidant and mitoprotective effects. Specific mechanisms include: salidroside from R. rosea activating PI3K/Akt; schizandrin B from S. chinensis stimulating Hsp70; withanolides from W. somnifera inhibiting PDE4D; ginsenosides from P. ginseng suppressing FKBP51; and bacosides from B. monnieri enhancing acetylcholine synthesis. Clinical studies confirm reductions in cortisol levels (14-30%), decreased fatigue, and improved cognitive function without adverse effects. Conclusions: Understanding the molecular mechanisms of adaptogens supports their application in integrative medicine for the treatment of stress-related disorders, depression, anxiety, and neurodegenerative diseases. Further clinical studies are needed to optimize dosages and standardize extracts. DOI: 10.3390/nu18060931 PMCID: PMC13029160 PMID: 41901106 [Indexed for MEDLINE] Conflict of interest statement: The authors declare that there is no conflict of interest.

Exploring the role of diet in modulating stress and emotional health: a review on mental nutrition and cognitive resilience.

26. J Sci Food Agric. 2026 Mar 11. doi: 10.1002/jsfa.70526. Online ahead of print. Exploring the role of diet in modulating stress and emotional health: a review on mental nutrition and cognitive resilience. Pandey VK(1), Tripathi A(2), Choudhary P(3), Thapliyal S(4). Author information: (1)Department of Food Science and Technology, Graphic Era (Deemed to be University), Dehradun, India. (2)Department of Biotechnology, School of Health Sciences, Dehradun, India. (3)Research & Development Cell, Biotechnology Department, Manav Rachna International Institute of Research and Studies (Deemed to be University), Faridabad, India. (4)Uttaranchal Institute of Technology, Uttaranchal University, Dehradun, India. The rise in mental-health-related disorders, including anxiety, depression, and cognitive impairment worldwide, has increased the demand for preventative non-pharmacological interventions and intervention aimed at modifiable lifestyle factors - particularly diet. Growing evidence shows that plant-based nutrition, with its anti-inflammatory and neuroprotective effects, is critically important for cognitive resilience, emotional stability, and mental wellbeing. Essential nutrient and bioactive compounds such as ω-3 fatty acids, polyphenols, B vitamins, magnesium, and probiotics themselves act on the gut-brain axis to alleviate neuroinflammatory stress. Functional and adaptogenic foods - for example, Ashwagandha, Rhodiola, and Holy Basil - are becoming the focus of interest as they play a significant role in cortisol control and stress adaptation. All plant-based dietary patterns, such as the Mediterranean, DASH (Dietary Approaches to Stop Hypertension), and plant-based diets, show comparable associations with lower risk for depression, anxiety, and cognitive deficits through enhancing gut microbiome richness and balancing neurotransmitters. This review outlines the scientific basis of mental nutrition, highlighting the interconnections between dietary patterns, gut microbiota composition, diet-mediated modulation of neurotransmitter levels, and neuroinflammatory pathways that collectively influence mental health. © 2026 Society of Chemical Industry. © 2026 Society of Chemical Industry. DOI: 10.1002/jsfa.70526 PMID: 41810763

Withania somnifera in Women's Hormonal Modulation: A Narrative Review With Implications for Polycystic Ovary Syndrome and Premenstrual Syndrome.

27. Cureus. 2026 Jan 13;18(1):e101431. doi: 10.7759/cureus.101431. eCollection 2026 Jan. Withania somnifera in Women's Hormonal Modulation: A Narrative Review With Implications for Polycystic Ovary Syndrome and Premenstrual Syndrome. Namysł M(1), Matczak S(2), Dachowska S(1), Haraj J(3), Majcherek E(1), Sobkowiak M(2), Bieniek M(2), Woźniak K(2). Author information: (1)Department of Medicine, Clinical University Hospital Poznan, Poznan, POL. (2)Department of Medicine, Poznan University of Medical Sciences, Poznan, POL. (3)Department of Medicine, Independent Public Healthcare Institution of the Ministry of the Interior and Administration in Poznań, Prof. Ludwik Bierkowski Hospital, Poznan, POL. BACKGROUND: Polycystic ovary syndrome (PCOS) and premenstrual syndrome (PMS) are among the most common hormonal diseases affecting women worldwide. Although multiple conventional treatments exist, they are often insufficient or poorly tolerated by the patients. Withania somnifera (WS) (ashwagandha) could provide a synergistic or alternative method of symptom management due to its endocrine, neuropsychiatric, and anti-inflammatory properties. AIM OF THE STUDY: This narrative review aims to evaluate the current evidence regarding the usefulness of Withania somnifera in aiding women's hormonal balance, with a particular focus on its potential applications in PCOS and PMS. RESULTS: The current state of knowledge indicates that by modulating the hypothalamic-pituitary-adrenal (HPA) and hypothalamic-pituitary-gonadal axes, normalization of gonadotropins and estradiol levels is potentially achievable with Withania somnifera. This, along with a well-documented lowering effect on cortisol, improvements in metabolic markers, and the restoration of ovarian function in preclinical PCOS models, shows therapeutic potential. Crucially, ashwagandha's impact on androgen levels appears sex-specific, as it does not seem to elevate testosterone in women, unlike in male study groups. In PMS, ashwagandha's neuropsychiatric properties, most likely associated with GABAergic signaling and HPA modulation, may be beneficial in lowering fatigue, anxiety, and stress reactivity. Some studies also indicate possible analgesic activity of Withania somnifera. CONCLUSIONS: Ashwagandha rises as a strong candidate for supportive treatment for managing the symptoms of PCOS and PMS by means of combined hormonal, metabolic, and neuropsychiatric effects. However, as current evidence relies heavily on preclinical models and extrapolation from other populations, further large-scale, randomized clinical trials using standardized extracts are necessary to establish definitive therapeutic protocols and confirm its clinical efficacy and safety. Copyright © 2026, Namysł et al. DOI: 10.7759/cureus.101431 PMCID: PMC12895992 PMID: 41694897 Conflict of interest statement: Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

Effects of multi-herb and ashwagandha root formulas on stress modulation: a randomized, double-blind, placebo-controlled clinical study.

28. Trials. 2026 Feb 9;27(1):205. doi: 10.1186/s13063-026-09495-9. Effects of multi-herb and ashwagandha root formulas on stress modulation: a randomized, double-blind, placebo-controlled clinical study. McKinney E(1), Stewart J(1), Kewalramani R(2), Singh S(3). Author information: (1)R&D Department, Gaia Herbs, Brevard, NC, USA. (2)The Kewalramani Clinic, Mumbai, India. (3)Clinical Development, Vedic Lifesciences, Mumbai, India. sonali.s@vediclifesciences.com. BACKGROUND: Chronic stress is detrimental to the maintenance of the main response system - the hypothalamic-pituitary-adrenal (HPA) axis. The current study aimed to investigate the efficacy of two plant-based adaptogens, a formula containing Rhodiola, holy basil and Schisandra chinensis (VL-G-A57) and a full-spectrum ashwagandha (VL-G-E12), on stress and related symptoms in individuals with high stress. MATERIALS AND METHODS: The 60-day randomized, double-blind, placebo-controlled clinical study included individuals aged between 18 to 65 years with a body mass index (BMI) of 18 to 29.9 kg/m2. One hundred eighty-six participants were randomized to one of the adaptogens, VL-G-A57 or VL-G-E12, or to placebo. The primary outcome was a reduction in stress levels. Secondary outcomes were changes in sleep quality, fatigue, restorative sleep, mental alertness, mood dysregulation, and anxiety. A priori power analysis determined the required sample size. Efficacy was assessed by comparing mean changes in the primary endpoint at days 30 and 60 using ANCOVA, with baseline values as covariates. Dunnett's post hoc test identified significant differences versus placebo, and within-group changes were evaluated using paired t-tests. Normality was assessed visually and via Shapiro-Wilk/Kolmogorov-Smirnov tests as needed. Secondary outcomes were analyzed similarly. Analyses were conducted using R (v4.0.5) and XLSTAT (v2021.3.1). RESULTS: At day 60, both VL-G-A57 and VL-G-E12 significantly reduced Perceived Stress Scale (PSS) scores compared to placebo (p < 0.0001). Sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI), improved significantly in both adaptogen groups (VL-G-A57: p = 0.0008, VL-G-E12: p < 0.0001). This corresponded well with the Restorative Sleep Questionnaire-Weekly (RSQ-W) results in the two IP arms when compared with placebo (p < 0.0001). Additionally, mood dysregulation (VL-G-A57: p = 0.0454), anxiety (VL-G-A57: p = 0.0004, VL-G-E12: p = 0.0015), and stress levels (VL-G-A57-VL-G-E12: p < 0.0001) showed significant improvements compared to placebo. No differences in mental alertness were observed. CONCLUSION: The study concluded that both VL-G-A57 and VL-G-E12 were associated with reductions in stress, fatigue, and anxiety while improving mood and sleep quality. TRIAL REGISTRATION: ClinicalTrials.gov NCT05602389 and the Clinical Trials Registry - India CTRI/2022/11/047635. Registered on 1 November 2022 and 24 November 2022. © 2026. The Author(s). DOI: 10.1186/s13063-026-09495-9 PMCID: PMC12983611 PMID: 41656269 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Ethics approval and consent to participate: The present study was conducted in compliance with the Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, General Assembly, Seoul 2008), International Conference on Harmonization–Good Clinical Practice (ICH–GCP) — 2016, and Ethical Guidelines for Biomedical Research on Human Participants, 2006 (Indian Council of Medical Research, India). It was approved by an Independent Ethics Committee, the Harmony Ethical Research Committee (Reg. No.: ECR/1411/Inst/MH/2020), to safeguard the rights, safety, and well-being of all trial participants. The participants who provided voluntary, written informed consent were enrolled in the study. Vedic Lifesciences, Mumbai, India, monitored and audited the study to ensure the study protocol and ICH-GCP compliance. The study report conformed to the Consolidated Standard Reporting of Trials (CONSORT) guidelines. Consent for publication: Not applicable. Competing interests: Erin McKinney and Jeremy Stewart were affiliated with Gaia Herbs during the conduct of the study. Rajesh Kewalramani served as both the principal investigator and as an author of this study, conducted under the supervision of Vedic Lifesciences. The authors declare no competing interests.

Effects of ashwagandha (Withania somnifera) on mental health in adults: A systematic review and dose-response meta-analysis of randomized controlled trials.

29. Complement Ther Med. 2026 May;97:103325. doi: 10.1016/j.ctim.2026.103325. Epub 2026 Feb 3. Effects of ashwagandha (Withania somnifera) on mental health in adults: A systematic review and dose-response meta-analysis of randomized controlled trials. Alsanie SA(1), Alhodieb FS(2), Askarpour M(3). Author information: (1)Department of Basic Health Sciences, College of Applied Medical Sciences, Qassim University, Saudi Arabia; Department of Clinical Nutrition, Medical City, Qassim University, Saudi Arabia. (2)Department of Basic Health Sciences, College of Applied Medical Sciences, Qassim University, Saudi Arabia. (3)Social Determinants of Health Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: askarpourmoein1994@gmail.com. BACKGROUND: Ashwagandha (Withania somnifera), as an important herbal medicine, has been increasingly recognized for its role in mental health management, particularly in reducing stress and anxiety, and reflects the growing relevance of complementary and alternative medicine in addressing psychological well-being. The present study aims to investigate its effectiveness by pooling the evidence from existing randomized controlled trials (RCTs). METHODS: Major medical databases of PubMed, Scopus, and Web of Science Core Collection were searched. Eligible studies were included. Meta-analysis, meta-regression, non-linear dose-response analysis, and subgroup analyses were conducted. Standardized mean differences (SMDs) were calculated. P-values < 0.05 were considered as statistically significant. The study protocol was registered in the PROSPERO database (CRD420251073134). RESULTS: Twenty-two studies met the eligibility criteria and were included. Meta-analysis revealed that supplementation with ashwagandha significantly improves stress (SMD = -5.88; 95 % CI: -8.15 to -3.60), depression (SMD = -5.68; 95 % CI: -8.43 to -2.94), and anxiety (SMD = -6.87; 95 % CI: -8.77 to -4.97). There was significant linear (coefficient = 0.005, P = 0.031) and non-linear (P-nonlinearity = 0.005) association between dosages of administered ashwagandha and stress levels. CONCLUSION: Current evidence suggests that ashwagandha supplementation holds promising potential in alleviating symptoms of stress, anxiety, and depression. However, to strengthen these findings and translate them into clinical recommendations, well-designed, high-quality trials are still needed to address existing heterogeneity and to establish the most effective dosages and intervention durations. Copyright © 2026 The Authors. Published by Elsevier Ltd.. All rights reserved. DOI: 10.1016/j.ctim.2026.103325 PMID: 41644067 [Indexed for MEDLINE] Conflict of interest statement: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Prakriti phenotyping in Central Serous Retinopathy (CSR): case series on Ayurvedic therapeutic outcomes in Vata individuals.

30. Front Med (Lausanne). 2025 Dec 18;12:1722235. doi: 10.3389/fmed.2025.1722235. eCollection 2025. Prakriti phenotyping in Central Serous Retinopathy (CSR): case series on Ayurvedic therapeutic outcomes in Vata individuals. K S(1), G G(2). Author information: (1)Amrita Vishwa Vidyapeetham Amrita School of Ayurveda, Kollam, India. (2)Govt Ayurveda Hospital, Kannur, India. BACKGROUND: Central Serous Retinopathy (CSR) is a retinal disorder characterized by serous detachment of the neurosensory retina, commonly associated with psychological stress and Type A personality traits. From an Ayurvedic perspective, these features correspond to Vata predominance, marked by hyperactivity, anxiety, and autonomic instability. Such individuals may be constitutionally predisposed to disorders of Vata imbalance, including retinal pathologies resembling Vataja Shopha. This case series explores therapeutic outcomes of Ayurvedic management in CSR among individuals with Vata Prakriti. CASE PRESENTATION: Three patients-two males (aged 65 and 46 years) and one female (aged 40 years), diagnosed with CSR and confirmed as Vata Prakriti through a standardized questionnaire, were treated with an identical Ayurvedic regimen comprising Ashwagandha tablets, Punarnavadi Kashaya, Tiktaka Ghrita, Kalyanaka Ghrita, and Triphala Churna. Local ocular therapies included Shiro Pichu with Brahmi Ghrita, Pratimarsha Nasya with Anu Taila, and Anjana Karma with Elaneer Kozhumbu. Lifestyle advice emphasized regular sleep, timely meals, guided meditation, and reduced screen exposure. All three patients demonstrated marked improvement in visual acuity and complete anatomical resolution of macular fluid on Optical Coherence Tomography within 4-17 months. No recurrence was observed over 1 year of follow-up. CONCLUSION: This case series highlights a possible association between CSR and Vata Prakriti. Vata pacifying and Rasayana based Ayurvedic interventions showed favorable visual and structural outcomes. Incorporating Prakriti phenotyping in ocular disease management may enhance personalized, integrative approaches to retinal disorders. Copyright © 2025 K and G. DOI: 10.3389/fmed.2025.1722235 PMCID: PMC12756344 PMID: 41488094 Conflict of interest statement: The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

The effect of Withania somnifera (Ashwagandha) on mental health symptoms in individuals with mental disorders: systematic review and meta-analysis.

31. BJPsych Open. 2025 Oct 27;11(6):e260. doi: 10.1192/bjo.2025.10885. The effect of Withania somnifera (Ashwagandha) on mental health symptoms in individuals with mental disorders: systematic review and meta-analysis. Marchi M(1)(2), Grenzi P(1), Travascio A(1)(2), Uberti D(1)(2), De Micheli E(1), Quartaroli F(1), Laquatra G(1), Pingani L(1)(2), Ferrari S(1)(2), Galeazzi GM(1)(2). Author information: (1)Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emiliahttps://ror.org/02d4c4y02, Modena, Italy. (2)Department of Mental Health and Drug Abuse, Azienda USL-IRCCS di Reggio Emiliahttps://ror.org/001bbwj30, Reggio Emilia, Italy. BACKGROUND: Withania somnifera (WS) is considered an adaptogen agent with reported antistress, cognition facilitating and anti-inflammatory properties, which may be beneficial in the treatment of mental disorders. AIMS: This systematic review investigated the efficacy and tolerability of Withania somnifera for mental health symptoms in individuals with mental disorders. METHOD: The protocol of this review was registered with PROSPERO (CRD42023467959). PubMed, Scopus, PsycINFO, CINAHL, Embase and CENTRAL were searched for randomised controlled trials comparing Withania somnifera to any comparator, in people of any age, with any mental disorder. The meta-analyses were based on standardised mean differences (SMDs) and odds ratios with 95% confidence intervals, estimated through frequentist and Bayesian-hierarchical models with random-effects. RESULTS: Fourteen studies, corresponding to 360 people treated with Withania somnifera and 353 controls were included. Anxiety disorders were the predominant diagnostic category. Thirteen trials administered Withania somnifera orally (median dose 600 mg/day), one with Shirodhara therapy. The median follow-up time was 8 weeks. Although limited by the small number of studies, substantial between-study heterogeneity, and outlier effects, our investigation showed Withania somnifera effectiveness in improving anxiety (outlier-corrected SMD: -1.13 (95% CI: -1.65; -0.60), pooled SMD: -1.962 (95% CI: -2.66; -0.57)), depression (SMD: -1.28 (95% CI: -2.40; -0.16) and stress (SMD: -0.95 (95% CI: -1.46; -0.43) symptoms and sleep quality (SMD: -1.35 (95% CI: -1.79; -0.91). The effect size was confirmed using the Bayesian for anxiety but not for depression. No significant difference between Withania somnifera and the comparators was found for safety and tolerability. CONCLUSIONS: We found evidence supporting the effectiveness of Withania somnifera in treating anxiety symptoms. Future trials should replicate this finding in larger samples and further clarify a possible Withania somnifera role in depression and insomnia treatment. DOI: 10.1192/bjo.2025.10885 PMCID: PMC12569615 PMID: 41140145 Conflict of interest statement: None.

A New Ashwagandha Formulation (Zenroot™) Alleviates Stress and Anxiety Symptoms While Improving Mood and Sleep Quality: A Randomized, Double-Blind, Placebo-Controlled Clinical Study.

32. Adv Ther. 2025 Oct;42(10):5238-5254. doi: 10.1007/s12325-025-03327-z. Epub 2025 Aug 28. A New Ashwagandha Formulation (Zenroot™) Alleviates Stress and Anxiety Symptoms While Improving Mood and Sleep Quality: A Randomized, Double-Blind, Placebo-Controlled Clinical Study. Mahadevan M(1), Gopukumar K(1), Gupta R(2), Morde A(3), Patni P(3), Srinivas SS(4), Bhuvanendran A(4), Phanindra A(5). Author information: (1), Bengaluru Neuro Center # No. 27/5, 10th Cross, 3rd Main, Margosa Road, Malleshwaram, Bengaluru, Karnataka, 560003, India. (2), Santosh Hospital # 6/1, Promenade Road, Near Coles Park, Bengaluru, Karnataka, 560005, India. (3)OmniActive Health Technologies, Phoenix House, T- 8, A Wing 462 Senapati Bapat Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India. (4)Invitro Research Solutions Private Limited, # 22 and 23, Kodigehalli Main Road, Sahakarnagar Post, Hebbal, Bengaluru, Karnataka, 560092, India. (5)Invitro Research Solutions Private Limited, # 22 and 23, Kodigehalli Main Road, Sahakarnagar Post, Hebbal, Bengaluru, Karnataka, 560092, India. abhijith@ivrs.org.in. INTRODUCTION: Prolonged exposure to stress may lead to low mood, anxiety, depression, insomnia, and metabolic disorders. Ashwagandha, an established adaptogen, is known to combat stress. We studied the safety and efficacy of Ashwagandha formulation, Zenroot™ (ZEN), containing 1.5% total withanolides on stress, anxiety, mood, and sleep quality in human subjects with non-chronic mild to moderate stress. METHODS: This was a prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study with supplementation duration of 84 days. Ninety subjects were randomly assigned in a 1:1 ratio to receive 125 mg of ZEN or placebo. We measured stress using the Perceived Stress Scale (PSS) score as a primary endpoint. Various secondary endpoints included Mindfield eSense Skin Response (SCR) and Mindfield eSense PULSE Heart Rate Variability (HRV)-Root Mean Square of Successive Differences (RMSSD), and standard deviation of normal NN interval (SDNN), Beck Anxiety Inventory (BAI), Profile of Mood States (POMS), Pittsburgh Sleep Quality Index (PSQI), stress biomarkers of serum cortisol, and salivary alpha amylase (sAA) levels and safety parameters. The study assessments were performed on days 0, 14, 28, 56, and 84. RESULTS: All 90 randomized subjects completed the study. Mean ± standard error (SE) age of subjects in the ZEN group was 35.5 ± 1.3 years and in the placebo group was 34.5 ± 1.2 years. ZEN 125 mg showed significant (p < 0.05) improvements in PSS, BAI, and PSQI scores on days 28, 56, and 84; SCR on days 14, 28, and 84 and trend (p < 0.1) on day 56; HRV-RMSSD and SDNN on day 14; and POMS on days 56 and 84. No significant differences were observed between the two groups for serum cortisol and sAA. The study product was well tolerated without any safety concerns. CONCLUSION: We observed significant reductions in both subjective and objective measures of stress with improvement in mood, sleep quality, and occasional anxiety symptoms. ZEN was well tolerated without any related adverse events. Future clinical studies are warranted to evaluate the effect of ZEN on chronically stressed adults. CLINICAL TRIAL REGISTRATION NUMBER: http://ctri.nic.in/ Identifier:CTRI/2024/03/063786. © 2025. The Author(s). DOI: 10.1007/s12325-025-03327-z PMCID: PMC12474591 PMID: 40875185 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Conflict of interest: Manasvi Mahadevan, Kumarpillai Gopukumar are the clinical investigators at Bengaluru Neuro Center, Ruchi Gupta is a clinical investigator at Santosh hospital. Sahitya Sarvamangala Srinivas, Arun Bhuvanendran and Abhijith Phanindra are employees of Invitro Research Solutions Private Limited. Abhijeet Morde and Paras Patni are employees of OmniActive Health Technologies. Ethical approval: All procedures performed in studies involving human participants were in accordance with the Good Clinical Practice guidelines, the ethical principles originated from Helsinki Declaration and in strict compliance with the “New Drugs and Clinical Trial Rules- 2019,” the Ministry of Health and the Government of India, at all stages of the trial for adherence to protocol. The study activities commenced after obtaining an approval from Santhosh Hospital Institutional Ethics Committee, Bengaluru, India, on the 21st February 2024. The EC was duly apprised of the progress and updates of the trial at regular intervals as per prescribed guidelines.

Neuroprotective and cognitive-enhancing potentials of herbal remedies: Focus on St. John's wort, green tea, and Ashwagandha.

33. Neurotoxicol Teratol. 2025 Sep-Oct;111:107549. doi: 10.1016/j.ntt.2025.107549. Epub 2025 Aug 25. Neuroprotective and cognitive-enhancing potentials of herbal remedies: Focus on St. John's wort, green tea, and Ashwagandha. Ahmed M(1). Author information: (1)Department of pharmacology, Faculty of veterinary medicine, Cairo university, Giza, Egypt. Electronic address: vet100539@stud.vet.cu.edu.eg. Neurodegenerative diseases and cognitive impairments represent significant global health challenges, necessitating the exploration of alternative and complementary therapeutic options. Herbal remedies, known for their bioactive compounds, have garnered attention for their potential neuroprotective and cognitive-enhancing effects. This review focuses on three widely studied herbal agents, including St. John's Wort (Hypericum perforatum), Green Tea (Camellia sinensis), and Ashwagandha (Withania somnifera) and evaluates their mechanisms in promoting brain health. St. John's Wort has demonstrated potential in alleviating symptoms of depression and anxiety, which are often linked to cognitive decline. Green Tea, rich in polyphenols such as epigallocatechin gallate (EGCG), has shown promise in improving memory function and providing antioxidant protection against neurotoxicity. Ashwagandha, an adaptogenic herb, is recognized for its neuroprotective properties, including reducing stress-induced cognitive deficits and promoting neuronal regeneration. The neuroprotective and cognitive-enhancing effects of these herbs are attributed to their antioxidative, anti-inflammatory, and neurotrophic properties, which collectively may support brain function and mitigate age-related cognitive decline. Copyright © 2025. Published by Elsevier Inc. DOI: 10.1016/j.ntt.2025.107549 PMID: 40865615 [Indexed for MEDLINE] Conflict of interest statement: Declaration of competing interest All data presented are accurate and not manipulated or falsified. The author agrees to the submission and takes responsibility for the content. The manuscript is original and has not been published elsewhere. This review does not involve any human or animal experiments, and all findings are based on previously published research. Misleading claims, sensationalism, or unsupported conclusions have been avoided to ensure scientific integrity.

Attenuation Effect of Withania somnifera Extract on Restraint Stress-Induced Anxiety-like Behavior and Hippocampal Alterations in Mice.

34. Int J Mol Sci. 2025 Jul 29;26(15):7317. doi: 10.3390/ijms26157317. Attenuation Effect of Withania somnifera Extract on Restraint Stress-Induced Anxiety-like Behavior and Hippocampal Alterations in Mice. Lee K(1), Lee D(1), Kim JY(1), Shim JJ(1), Bae JW(2), Lee JH(1). Author information: (1)R&BD Center, hy Co., Ltd., 22 Giheungdanji-ro, 24 Beon-gil, Giheung-gu, Yongin-si 17086, Republic of Korea. (2)3HLABS Co., Ltd., 240, Kintex-ro, Ilsanseo-gu, Goyang-si 10391, Republic of Korea. Stress is a major factor that threatens the body's homeostasis or well-being. Excessive stress causes psychological anxiety and tension, which disrupts the balance of the autonomic nervous system that maintains the body's balance, resulting in hormonal imbalance and brain changes. In this study, we investigated the effects of Withania somnifera (Ashwagandha) extract on depression, neurobehavior, and hippocampal changes in model mice exposed to stress. Using an excessive restraint stress-induced depression model, we measured the behavioral changes and the levels of brain-derived neurotrophic factor (BDNF) and antioxidant genes in five groups: control, stress, low-dose W. somniferous extract (20 mg/kg/day), high-dose W. somniferous extract (40 mg/kg/day), and L-theanine (50 mg/kg/day, positive control). Stressed mice showed poorer performance in the open field and elevated plus maze tests compared with the control group. The impaired performance was restored following W. somniferous extract administration. In addition, W. somniferous extract restored the decreased expression of BDNF in the hippocampus caused by restraint stress, improved the balance of stress hormones (i.e., cortisol, dopamine, and norepinephrine), and also regulated BDNF, inflammatory genes, and antioxidant genes in brain tissue. Therefore, W. somniferous extract can induce antidepressant and anti-stress effects by maintaining brain BDNF expression and preventing hippocampal tissue alterations caused by restraint stress. DOI: 10.3390/ijms26157317 PMCID: PMC12347074 PMID: 40806449 [Indexed for MEDLINE] Conflict of interest statement: All of the authors were employed in hy Co., Ltd. or 3HLABS Co., Ltd. The authors declare that the research was conducted in the absence of any other commercial or financial relationships that could be construed as a potential conflict of interest.

Herbal Medicines in Autism Spectrum Disorder: Therapeutic Potential, Plant Components, and Dosage Guidelines.

35. Altern Ther Health Med. 2025 Oct;31(6):76-89. Herbal Medicines in Autism Spectrum Disorder: Therapeutic Potential, Plant Components, and Dosage Guidelines. Aldekhail NM(1), Khojah H(1), Alsaadoun NH(2), Al-Sanea MM(3), Alshammari SB(4), Alhazeemi AH(5), Aldekhail AM(6), Aldekhail KM(7), Alazmi BH(8), Alrayes RA(9), Aljaber AM(3), Alanazi L(3), Agili AAA(10), Gamal M(11). Author information: (1)Department of Pharmacy, College of Pharmacy, Nursing and Medical Sciences, Riyadh Elm University, Riyadh, Saudi Arabia. (2)Department of Medical Laboratory Sciences, College of Pharmacy, Nursing and Medical Sciences, Riyadh Elm University, Riyadh, Saudi Arabia. (3)Department of Pharmacognosy, College of Pharmacy, Jouf University, Sakaka, Al-Jouf, Saudi Arabia. (4)Department of Pharmacy, Rafha Central Hospital, Rafha, Northern Border, Saudi Arabia. (5)Department of Pharmacy, North Medical Tower Hospital, Arar, Northern Border, Saudi Arabia. (6)Department of Pharmacy, Prince Sultan Military Medical City, Riyadh, Saudi Arabia. (7)Department of Internal Medicine, Al Iman General Hospital. Riyadh, Saudi Arabia. (8)Department of Pharmacy, Qurayyat General Hospital. Aljouf, Saudi Arabia. (9)College of Pharmacy, Al Jouf University, Saudi Arabia. (10)Department of Pharmaceutical Care, King Saud Medical City, Riyadh First Health Cluster, Saudi Arabia. (11)Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt. BACKGROUND: Autism spectrum disorder (ASD), marked by social communication deficits and repetitive behaviors, significantly impacts the quality of life for kids and caregivers. Herbal medicines help manage symptoms, yet no comprehensive review has collectively summarized recent evidence (2018-mid-2025). METHODS: This narrative review utilized searches across PubMed, Scopus, Web of Science, and Google Scholar to identify studies published on herbal medicines for ASD. Inclusion criteria prioritized clinical trials and preclinical studies detailing plant bioactive compounds, dosing, and mechanisms. KEY FINDINGS: Prominent herbs include Bacopa monnieri, which can enhance cognitive flexibility via bacosides; Curcuma longa (curcumin), which can reduce oxidative stress and repetitive behaviors; and Green Tea Extract (luteolin), which can modulate neuroinflammation. Cannabinoids show modest improvements in sleep and social engagement, while Ginkgo biloba improves cerebral blood flow. Passionflower and Valerian Root alleviate anxiety and hyperactivity through GABAergic pathways, and probiotic-fermented herbal combinations target gut-brain axis dysfunction. Ashwagandha demonstrates neuroprotective effects in preclinical trials. CLINICAL IMPLICATIONS: Herbal therapies may address core ASD symptoms (anxiety and hyperactivity) and comorbidities (sleep disturbances and gastrointestinal issues). However, standardization of herbal formulations and rigorous dosing protocols are needed. Integrative approaches combining herbs with behavioral therapies show accepted synergistic potential but require further validation. While herbal medicine may offer supportive benefits, it should never be intended to replace other evidence-based therapies (e.g., applied behavior analysis and speech therapy). FUTURE DIRECTIONS: Large-scale randomized clinical trials are crucial to confirming efficacy, safety, and optimal dosing. Research must address herb-drug interactions, long-term effects, and biomarkers for personalized treatment. KEYWORDS: autism spectrum disorder, herbal medicines, narrative review, doses recommendation, therapeutic effects, side effects. PMID: 40768551 [Indexed for MEDLINE]

Superior Bioavailability of a Novel 1.5% Ashwagandha Formulation (Zenroot™): A Randomized, Double-Blind, Single-Dose, Comparative, Oral Bioavailability Study in Healthy Adults.

36. Adv Ther. 2025 Oct;42(10):4964-4976. doi: 10.1007/s12325-025-03292-7. Epub 2025 Aug 1. Superior Bioavailability of a Novel 1.5% Ashwagandha Formulation (Zenroot™): A Randomized, Double-Blind, Single-Dose, Comparative, Oral Bioavailability Study in Healthy Adults. Ramapalaniappan A(1), Loganathan V(1), Morde A(2), Padigaru M(2), Patni P(2), Joshua L(3), Thomas JV(4). Author information: (1)Spinos Life Science and Research Private Limited, 29 A, Krishna Madura Vanam, Vellakinar Pirivu, Thudiyalur, Coimbatore, 641029, Tamil Nadu, India. (2)OmniActive Health Technologies, Phoenix House, T-8, A Wing 462 Senapati Bapat Marg, Lower Parel, Mumbai, 400 013, Maharashtra, India. (3)Leads Clinical Research and Bio Services Pvt. Ltd., No. 9, 1st Floor Mythri Legacy, Kalyan Nagar, Chelekere Main Road, Bengaluru, 560043, Karnataka, India. (4)Leads Clinical Research and Bio Services Pvt. Ltd., No. 9, 1st Floor Mythri Legacy, Kalyan Nagar, Chelekere Main Road, Bengaluru, 560043, Karnataka, India. jestin@leadsbio.com. INTRODUCTION: Ashwagandha has multiple medicinal properties and is widely used as a supplement to address various health conditions including stress and anxiety. The bioavailability of Ashwagandha bioactives provide critical information on the biological effects in humans after oral supplementation. METHODS: A randomized, double-blind, single-dose, cross-over comparative oral bioavailability study was conducted in 20 healthy, adult human subjects under fasting conditions. All subjects consumed single dose of ZEN 1.5 (Zenroot™ Ashwagandha 1.5% 125 mg), ASH 5 (Reference product 1-Ashwagandha 5% 600 mg) and ASH 10 (Reference product 2-Ashwagandha 10% 500 mg) as per a randomization schedule. Blood samples were collected at 0.00 h, and at 00.25, 00.50, 00.75, 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 09.00, 12.00, and 24.00 h post-dose. Total withanolides (consisting of withanoside IV, withanolide A, 12-deoxywithastramonolide, and withaferin A) were quantified in plasma using the LC-MS/MS method and pharmacokinetics parameters like area under the curve, AUC0-t, Cmax, Tmax, t½ and test/reference (T/R) ratio for test product, ZEN 1.5, versus reference products, ASH 5 and ASH 10, were used for statistical comparisons. RESULTS: Subjects in the ZEN 1.5 group showed significantly (P < 0.05) higher total withanolides concentration in plasma at all post-dose time points except 12.00 and 24.00 h compared to ASH 5. In addition, subjects in Ashwagandha ZEN 1.5 group showed significantly higher (P < 0.05) total withanolides concentration in plasma at 0.25, 1.00, 2.00, 3.0, and 4.00 h compared to ASH 10. Further, ZEN 1.5 showed significantly higher bioavailability for total withanolides compared to ASH 5 and ASH 10 with significantly higher (P < 0.05) Cmax and AUC0-t parameters, T/R ratio, and 90% CI. ZEN 1.5 at 125-mg dose showed 2.1-fold higher bioavailability compared to ASH 5 at 600 mg, and 1.3-fold higher bioavailability compared to ASH 10 at 500 mg. ZEN 1.5 was well tolerated during the study period. CONCLUSION: A low dose of 125 mg of ZEN 1.5 showed greater total withanolides bioavailability compared to reference products. The Cmax and AUC parameters were significantly higher than the 80-125% criteria established by the FDA for bioequivalence confirming superior bioavailability of ZEN 1.5. In addition, ZEN 1.5 was well tolerated by subjects throughout the study duration. Further studies are warranted for evaluating the health benefits of ZEN 1.5. TRIAL REGISTRATION: CTRI/2022/11/047039. © 2025. The Author(s). DOI: 10.1007/s12325-025-03292-7 PMCID: PMC12474700 PMID: 40748423 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Conflict of Interest: Muralidhara Padigaru, Abhijeet Morde, and Paras Patni are employees of OmniActive Health Technologies Limited. R Abiraamasundari, L Vijayakrishnan, Lincy Joshua, and Jestin V. Thomas declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Ethical Approval: Institutional ethics approval was obtained from ‘The Research Ethics Committee’ Coimbatore, India. This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with the International Conference on Harmonization (ICH), Good Clinical Practice (GCP) Guidelines, as well as in strict compliance with the “The New Drugs and Clinical Trial Rules- 2019”, the Ministry of Health and Family Welfare and the Government of India at all stages of the trial for adherence to protocol and compliance with ethical and regulatory guidelines. Voluntary consent was obtained in written from all the study participants before commencing any study related activities. The EC was duly apprised of the progress and updates of the trial at regular intervals as per prescribed guidelines.