샤타바리

Efficacy and safety of Shatavari root extract in women with Polycystic Ovarian Syndrome: a randomized, double-blind, placebo-controlled trial.

1. Front Endocrinol (Lausanne). 2026 Feb 24;17:1769773. doi: 10.3389/fendo.2026.1769773. eCollection 2026. Efficacy and safety of Shatavari root extract in women with Polycystic Ovarian Syndrome: a randomized, double-blind, placebo-controlled trial. Mhatre Y(1), Jadhav P(2), Malik A(3), Srivaths

Shatavari (Asparagus racemosus Willd) root extract for postpartum lactation: A randomised, double-blind, placebo-controlled study.

2. J Obstet Gynaecol. 2025 Dec;45(1):2564168. doi: 10.1080/01443615.2025.2564168. Epub 2025 Oct 7. Shatavari (Asparagus racemosus Willd) root extract for postpartum lactation: A randomised, double-blind, placebo-controlled study. Ajgaonkar A(1), Debnath T(2), Bhatnagar S(3), Debnath K(4), Langad

Shatavari supplementation in postmenopausal women alters the skeletal muscle proteome and pathways involved in training adaptation.

1. Eur J Nutr. 2024 Apr;63(3):869-879. doi: 10.1007/s00394-023-03310-w. Epub 2024 Jan 12. Shatavari supplementation in postmenopausal women alters the skeletal muscle proteome and pathways involved in training adaptation. O'Leary MF(1), Jackman SR(2), Bowtell JL(2). Author information: (1)Department of Public Health and Sport Sciences, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK. m.oleary@exeter.ac.uk. (2)Department of Public Health and Sport Sciences, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK. PURPOSE: Shatavari is an understudied, widely available herbal supplement. It contains steroidal saponins and phytoestrogens. We previously showed that six weeks of shatavari supplementation improved handgrip strength and increased markers of myosin contractile function. Mechanistic insights into shatavari's actions are limited. Therefore, we performed proteomics on vastus lateralis (VL) samples that remained from our original study. METHODS: In a randomised double-blind trial, women (68.5 ± 6 years) ingested either placebo or shatavari (equivalent to 26,500 mg/d fresh weight) for six weeks. Tandem mass tag global proteomic analysis of VL samples was conducted (N = 7 shatavari, N = 5 placebo). Data were normalized to total peptides and scaled using a reference sample. Data were filtered using a 5% FDR. For each protein, the pre to post supplementation difference was expressed as log2 fold change. Welch's t tests with Benjamini-Hochberg corrections were performed for each protein. Pathway enrichment (PADOG, CAMERA) was interrogated in Reactome (v85). RESULTS: No individual protein was significantly different between supplementation conditions. Both PADOG and CAMERA indicated that pathways related to (1) Integrin/MAPK signalling, (2) metabolism/insulin secretion; (3) cell proliferation/senescence/DNA repair/cell death; (4) haemostasis/platelets/fibrin; (5) signal transduction; (6) neutrophil degranulation and (7) chemical synapse function were significantly upregulated. CAMERA indicated pathways related to translation/amino acid metabolism, viral infection, and muscle contraction were downregulated. CONCLUSION: Our analyses indicate that shatavari may support muscle adaptation responses to exercise. These data provide useful signposts for future investigation of shatavari's utility in conserving and enhancing musculoskeletal function in older age. TRIAL REGISTRATION: NCT05025917 30/08/21, retrospectively registered. © 2024. The Author(s). DOI: 10.1007/s00394-023-03310-w PMCID: PMC10948523 PMID: 38214710 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflict of interest.

Evaluation of immunostimulatory attributes of Asparagus racemosus and Withania somnifera supplemented diets in fish, Channa punctatus (Bloch, 1793).

2. Vet Immunol Immunopathol. 2023 Apr;258:110561. doi: 10.1016/j.vetimm.2023.110561. Epub 2023 Feb 9. Evaluation of immunostimulatory attributes of Asparagus racemosus and Withania somnifera supplemented diets in fish, Channa punctatus (Bloch, 1793). Trivedi SP(1), Dwivedi S(2), Singh S(3), Khan AA(4), Kumar M(5), Shukla A(6), Dwivedi S(7), Kumar V(8), Yadav KK(9), Tiwari V(10). Author information: (1)Centre of Excellence in Fish Nutrigenomics, Department of Zoology, University of Lucknow, Lucknow 226007, India. Electronic address: sat060523@gmail.com. (2)Environmental Toxicology & Bioremediation Laboratory, Department of Zoology, University of Lucknow, Lucknow 226007, India. (3)Environmental Toxicology & Bioremediation Laboratory, Department of Zoology, University of Lucknow, Lucknow 226007, India. Electronic address: shefalee.singh@gmail.com. (4)Environmental Toxicology & Bioremediation Laboratory, Department of Zoology, University of Lucknow, Lucknow 226007, India. Electronic address: adeelkhan756@gmail.com. (5)Environmental Toxicology & Bioremediation Laboratory, Department of Zoology, University of Lucknow, Lucknow 226007, India. Electronic address: mk2016lu@gmail.com. (6)Environmental Toxicology & Bioremediation Laboratory, Department of Zoology, University of Lucknow, Lucknow 226007, India. Electronic address: anubha012@gmail.com. (7)Department of Zoology, Government Degree College, Haripur Nihastha, Raebareli 229208, India. Electronic address: shraddhadwivedi2013@gmail.com. (8)Department of Zoology, Isabella Thoburn PG College, Lucknow 226007, India. Electronic address: vivekkumarsb@gmail.com. (9)Department of Zoology, Government Degree College, Bakkha Kheda, Unnao 209801, India. Electronic address: drkkyadav8@gmail.com. (10)Institute of Food Processing and Technology, University of Lucknow, Lucknow 226007, India. Electronic address: vntibt@gmail.com. With the progression of aquaculture industry, there has been a spurt in dietary supplementation with economically viable medicinal herbs having enough immunostimulatory potential. This also aids in avoidance of environmentally undesirable therapeutics that are almost inevitable to safeguard fish against an array of diseases in aquaculture practices. The study aims to determine the optimal dose of herbs that can stimulate substantial immune response in fish for reclamation of aquaculture. Immunostimulatory potential of the two medicinal herbs- Asparagus racemosus (Shatavari), Withania somnifera (Ashwagandha), individually, and in combination, with a basal diet was screened up to 60 days in Channa punctatus. 300 laboratory acclimatized healthy fish (14 ± 1 g; 11 ± 1 cm) were divided into ten groups- C, S1, S2, S3, A1, A2, A3, AS1, AS2, and AS3, based on the composition of dietary supplementation, in triplicates, with 10 specimens per group. The hematological index, total protein and lysozyme enzyme activity were performed after 30 and 60 days, while qRT-PCR analysis of lysozyme expression was done after 60 days of the feeding trial. The significant (P < 0.05) increments in hematological indices- (TEC, TLC, DLC, Hb, Hct, MCV, MCH and MCHC), total protein content and serum lysozyme activity, after 30 and 60 days; whereas upregulation of lysozyme transcript levels, both in liver and muscle tissues after 60 days of the feeding trial were recorded in groups- AS1, AS2, and AS3. The maximal increment in lysozyme expression was recorded in AS3, both in liver and muscle tissues, with 3.75 ± 0.13 and 3.21 ± 0.18-folds, respectively. However, increments were non-significant (P > 0.05) for MCV in AS2 and AS3 after 30 days; and for MCHC in AS1 for both the durations; whereas in AS2 and AS3, after 60 days of the feeding trial. A positive correlation (P < 0.05) among lysozyme expression, MCH, lymphocytes, neutrophils, total protein content, and serum lysozyme activity in AS3, after 60 days, conclusively, evinces that a 3% dietary supplementation with both A. racemosus and W. somnifera enhances immunity and health profile of the fish, C. punctatus. The study, thus finds ample scope in augmentation of aquaculture production and also paves the way for more researches for biological screenings of potential immunostimulatory medicinal herbs that can be appropriately incorporated in the fish diet. Copyright © 2023 Elsevier B.V. All rights reserved. DOI: 10.1016/j.vetimm.2023.110561 PMID: 36801726 [Indexed for MEDLINE] Conflict of interest statement: Declaration of interests None.

Shatavari Supplementation in Postmenopausal Women Improves Handgrip Strength and Increases Vastus lateralis Myosin Regulatory Light Chain Phosphorylation but Does Not Alter Markers of Bone Turnover.

3. Nutrients. 2021 Nov 27;13(12):4282. doi: 10.3390/nu13124282. Shatavari Supplementation in Postmenopausal Women Improves Handgrip Strength and Increases Vastus lateralis Myosin Regulatory Light Chain Phosphorylation but Does Not Alter Markers of Bone Turnover. O'Leary MF(1), Jackman SR(1), Sabou VR(1), Campbell MI(1), Tang JCY(2), Dutton J(2), Bowtell JL(1). Author information: (1)Sport and Health Sciences, College of Life and Environmental Sciences, Exeter University, Exeter EX1 2LU, UK. (2)Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich NR4 7TJ, UK. Shatavari has long been used as an Ayurvedic herb for women's health, but empirical evidence for its effectiveness has been lacking. Shatavari contains phytoestrogenic compounds that bind to the estradiol receptor. Postmenopausal estradiol deficiency contributes to sarcopenia and osteoporosis. In a randomised double-blind trial, 20 postmenopausal women (68.5 ± 6 years) ingested either placebo (N = 10) or shatavari (N = 10; 1000 mg/d, equivalent to 26,500 mg/d fresh weight shatavari) for 6 weeks. Handgrip and knee extensor strength were measured at baseline and at 6 weeks. Vastus lateralis (VL) biopsy samples were obtained. Data are presented as difference scores (Week 6-baseline, median ± interquartile range). Handgrip (but not knee extensor) strength was improved by shatavari supplementation (shatavari +0.7 ± 1.1 kg, placebo -0.4 ± 1.3 kg; p = 0.04). Myosin regulatory light chain phosphorylation, a known marker of improved myosin contractile function, was increased in VL following shatavari supplementation (immunoblotting; placebo -0.08 ± 0.5 a.u., shatavari +0.3 ± 1 arbitrary units (a.u.); p = 0.03). Shatavari increased the phosphorylation of Aktser473 (Aktser473 (placebo -0.6 ± 0.6 a.u., shatavari +0.2 ± 1.3 a.u.; p = 0.03) in VL. Shatavari supplementation did not alter plasma markers of bone turnover (P1NP, β-CTX) and stimulation of human osteoblasts with pooled sera (N = 8 per condition) from placebo and shatavari supplementation conditions did not alter cytokine or metabolic markers of osteoblast activity. Shatavari may improve muscle function and contractility via myosin conformational change and further investigation of its utility in conserving and enhancing musculoskeletal function, in larger and more diverse cohorts, is warranted. DOI: 10.3390/nu13124282 PMCID: PMC8708006 PMID: 34959836 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflict of interest.

Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants.

4. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Foong SC(1), Tan ML(1), Foong WC(1), Marasco LA(2), Ho JJ(1), Ong JH(3). Author information: (1)Department of Paediatrics, RCSI & UCD Malaysia Campus (formerly Penang Medical College), George Town, Malaysia. (2)Santa Barbara County Public Health Department, Nutrition Services/Breastfeeding Program, Santa Maria, California, USA. (3)C/O Department of Paediatrics, RCSI & UCD Malaysia Campus (formerly Penang Medical College), George Town, Malaysia. Update of doi: 10.1002/14651858.CD011505. BACKGROUND: Many women express concern about their ability to produce enough milk, and insufficient milk is frequently cited as the reason for supplementation and early termination of breastfeeding. When addressing this concern, it is important first to consider the influence of maternal and neonatal health, infant suck, proper latch, and feeding frequency on milk production, and that steps be taken to correct or compensate for any contributing issues. Oral galactagogues are substances that stimulate milk production. They may be pharmacological or non-pharmacological (natural). Natural galactagogues are usually botanical or other food agents. The choice between pharmacological or natural galactagogues is often influenced by familiarity and local customs. Evidence for the possible benefits and harms of galactagogues is important for making an informed decision on their use. OBJECTIVES: To assess the effect of oral galactagogues for increasing milk production in non-hospitalised breastfeeding mother-term infant pairs. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), Health Research and Development Network - Phillippines (HERDIN), Natural Products Alert (Napralert), the personal reference collection of author LM, and reference lists of retrieved studies (4 November 2019). SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs (including published abstracts) comparing oral galactagogues with placebo, no treatment, or another oral galactagogue in mothers breastfeeding healthy term infants. We also included cluster-randomised trials but excluded cross-over trials. DATA COLLECTION AND ANALYSIS: We used standard Cochrane Pregnancy and Childbirth methods for data collection and analysis. Two to four review authors independently selected the studies, assessed the risk of bias, extracted data for analysis and checked accuracy. Where necessary, we contacted the study authors for clarification. MAIN RESULTS: Forty-one RCTs involving 3005 mothers and 3006 infants from at least 17 countries met the inclusion criteria. Studies were conducted either in hospitals immediately postpartum or in the community. There was considerable variation in mothers, particularly in parity and whether or not they had lactation insufficiency. Infants' ages at commencement of the studies ranged from newborn to 6 months. The overall certainty of evidence was low to very low because of high risk of biases (mainly due to lack of blinding), substantial clinical and statistical heterogeneity, and imprecision of measurements. Pharmacological galactagogues Nine studies compared a pharmacological galactagogue (domperidone, metoclopramide, sulpiride, thyrotropin-releasing hormone) with placebo or no treatment. The primary outcome of proportion of mothers who continued breastfeeding at 3, 4 and 6 months was not reported. Only one study (metoclopramide) reported on the outcome of infant weight, finding little or no difference (mean difference (MD) 23.0 grams, 95% confidence interval (CI) -47.71 to 93.71; 1 study, 20 participants; low-certainty evidence). Three studies (metoclopramide, domperidone, sulpiride) reported on milk volume, finding pharmacological galactagogues may increase milk volume (MD 63.82 mL, 95% CI 25.91 to 101.72; I² = 34%; 3 studies, 151 participants; low-certainty evidence). Subgroup analysis indicates there may be increased milk volume with each drug, but with varying CIs. There was limited reporting of adverse effects, none of which could be meta-analysed. Where reported, they were limited to minor complaints, such as tiredness, nausea, headache and dry mouth (very low-certainty evidence). No adverse effects were reported for infants. Natural galactagogues Twenty-seven studies compared natural oral galactagogues (banana flower, fennel, fenugreek, ginger, ixbut, levant cotton, moringa, palm dates, pork knuckle, shatavari, silymarin, torbangun leaves or other natural mixtures) with placebo or no treatment. One study (Mother's Milk Tea) reported breastfeeding rates at six months with a concluding statement of "no significant difference" (no data and no measure of significance provided, 60 participants, very low-certainty evidence). Three studies (fennel, fenugreek, moringa, mixed botanical tea) reported infant weight but could not be meta-analysed due to substantial clinical and statistical heterogeneity (I2 = 60%, 275 participants, very low-certainty evidence). Subgroup analysis shows we are very uncertain whether fennel or fenugreek improves infant weight, whereas moringa and mixed botanical tea may increase infant weight compared to placebo. Thirteen studies (Bu Xue Sheng Ru, Chanbao, Cui Ru, banana flower, fenugreek, ginger, moringa, fenugreek, ginger and turmeric mix, ixbut, mixed botanical tea, Sheng Ru He Ji, silymarin, Xian Tong Ru, palm dates; 962 participants) reported on milk volume, but meta-analysis was not possible due to substantial heterogeneity (I2 = 99%). The subgroup analysis for each intervention suggested either benefit or little or no difference (very low-certainty evidence). There was limited reporting of adverse effects, none of which could be meta-analysed. Where reported, they were limited to minor complaints such as mothers with urine that smelled like maple syrup and urticaria in infants (very low-certainty evidence). Galactagogue versus galactagogue Eight studies (Chanbao; Bue Xue Sheng Ru, domperidone, moringa, fenugreek, palm dates, torbangun, moloco, Mu Er Wu You, Kun Yuan Tong Ru) compared one oral galactagogue with another. We were unable to perform meta-analysis because there was only one small study for each match-up, so we do not know if one galactagogue is better than another for any outcome. AUTHORS' CONCLUSIONS: Due to extremely limited, very low certainty evidence, we do not know whether galactagogues have any effect on proportion of mothers who continued breastfeeding at 3, 4 and 6 months. There is low-certainty evidence that pharmacological galactagogues may increase milk volume. There is some evidence from subgroup analyses that natural galactagogues may benefit infant weight and milk volume in mothers with healthy, term infants, but due to substantial heterogeneity of the studies, imprecision of measurements and incomplete reporting, we are very uncertain about the magnitude of the effect. We are also uncertain if one galactagogue performs better than another. With limited data on adverse effects, we are uncertain if there are any concerning adverse effects with any particular galactagogue; those reported were minor complaints. High-quality RCTs on the efficacy and safety of galactagogues are urgently needed. A set of core outcomes to standardise infant weight and milk volume measurement is also needed, as well as a strong basis for the dose and dosage form used. Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. DOI: 10.1002/14651858.CD011505.pub2 PMCID: PMC7388198 PMID: 32421208 [Indexed for MEDLINE] Conflict of interest statement: Siew Cheng Foong: none known
May Loong Tan: none known
Wai Cheng Foong: none known
Lisa A Marasco is co‐author of a breastfeeding book 'Making More Milk: The Breastfeeding Guide to Increasing Your Milk Production' (published by McGraw‐Hill) which discusses galactogogues. She also speaks on various lactation‐related topics, including galactogogues, providing training and continuing education units to lactation consultants and other health care providers.
Jacqueline J Ho is co‐coordinator of the local governance board of the World Alliance for Breastfeeding Action (WABA). A member of her family works for a pharmaceutical company.
Joo Howe Ong: none known

A Standardized Asparagus Racemosus Root Extract Improves Hormonal Balance and Menstrual Health and Reduces Vasomotor Symptoms in Perimenopausal Women: A Randomized, Double-Blind, Placebo-Controlled Study.

5. J Am Nutr Assoc. 2025 Nov-Dec;44(8):754-764. doi: 10.1080/27697061.2025.2510474. Epub 2025 May 28. A Standardized Asparagus Racemosus Root Extract Improves Hormonal Balance and Menstrual Health and Reduces Vasomotor Symptoms in Perimenopausal Women: A Randomized, Double-Blind, Placebo-Controlled Study. Yadav P(1), Yadav S(2), Vedururu SS(3), Kumari G(4). Author information: (1)Department of Gynecology, Lifeline Hospital & Research Center, Uttar Pradesh, Azamgarh, India. (2)Department of Radiology, Pratap Diagnostic Centre, Uttar Pradesh, Azamgarh, India. (3)Department of Research Labs, Asian Health Care Foundation, Hyderabad, India. (4)Department of General Medicine, Lifeline Hospital & Research Center, Uttar Pradesh, Azamgarh, India. BACKGROUND: Perimenopausal women often experience dysmenorrhea, menstrual cramps, hormonal imbalances and vasomotor symptoms (VMS), significantly affecting their quality of life. In Ayurveda, Asparagus racemosus (Shatavari) root extract has been used for female reproductive health. This study evaluated the safety and efficacy of CL22205, a standardized A. racemosus root extract, in managing perimenopausal symptoms. METHODS: This randomized, double-blind, placebo-controlled trial was conducted on 50 perimenopausal women (age: 40-50 years) experiencing mild to moderate climacteric symptoms. Participants received either CL22205 (200 mg/day) or placebo over a period of 120 consecutive days. Primary outcome measure was Menopausal Rating Scale (MRS) scores. Secondary measures assessed Hot Flash Weekly Weighted Score (HFWWS), Menstrual Symptom Questionnaire (MSQ), ovarian follicular number using ultrasonography, serum Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Anti-Müllerian Hormone (AMH), and 17β-Estradiol (E2), skin and hair quality, and patient satisfaction using Integrative Medicine Patient Satisfaction & Outcome Scales (IMPSS & IMOS). Serum biochemistry, hematology, and urine analysis were performed for safety evaluation. RESULTS: CL22205 significantly reduced (p < 0.001) total MRS scores and HFWWS vs. placebo and baseline after 120 days of treatment, menstrual symptoms (congestive and spasmodic dysmenorrhea) were improved (p < 0.001). CL22205 decreased serum FSH (56.3%), LH (34.3%), and increased AMH (188.1%, p < 0.001) levels. Skin and hair quality improved significantly (p < 0.001), with no adverse events. CONCLUSION: CL22205 effectively reduces VMS, menstrual discomfort, and hormonal imbalances while improving skin and hair health, offering a safe and natural alternative for perimenopausal symptoms management. DOI: 10.1080/27697061.2025.2510474 PMID: 40434025 [Indexed for MEDLINE]

Efficacy and Safety of Shatavari Root Extract for the Management of Menopausal Symptoms: A Double-Blind, Multicenter, Randomized Controlled Trial.

6. Cureus. 2024 Apr 8;16(4):e57879. doi: 10.7759/cureus.57879. eCollection 2024 Apr. Efficacy and Safety of Shatavari Root Extract for the Management of Menopausal Symptoms: A Double-Blind, Multicenter, Randomized Controlled Trial. Gudise VS(1), Dasari MP(2), Kuricheti SSK(3). Author information: (1)Obstetrics and Gynecology, Good Life Hospital, Vijayawada, IND. (2)Obstetrics and Gynecology, Ravi Nursing Home, Guntur, IND. (3)Auyrvedic Medicine, Rasashastra and Bhaishajya Kalpana, Sree Jeevana Ayurveda, Vijayawada, IND. Background Menopause is a physiological state that occurs in all women and refers to the halt of the reproductive phase. The cessation of the reproductive phase occurs through various stages and presents different symptoms such as hot flashes, night sweats, insomnia, anxiety, depression, and irritability. Such pre- and post-menopausal symptoms may affect the daily activities and production capacities of women, impacting the quality of life (QoL) of women. Hormone replacement therapy (HRT) is primarily used to manage menopausal symptoms. However, various side effects have been reported related to HRT. Therefore, women are choosing alternative medicine such as Ayurveda that can benefit them with less or no adverse effects. Shatavari (Asparagus racemosus) is known in Ayurveda as an effective medicinal plant source for various women's health remedies since ancient times. This study aimed to evaluate the safety and efficacy of the Ayurvedic Shatavari formulation on menopausal symptoms compared to the placebo. Methodology This is a randomized, double-blinded, multicenter, placebo-controlled, clinical study. Altogether, 70 patients were randomized to two groups, i.e., the test group (active group) and the placebo group (microcrystalline cellulose), with 35 participants in each group. Results The study outcomes showed a positive and significant effect of the active test ingredient over the placebo in terms of reduction in hot flashes, night sweats, insomnia, anxiety, nervousness, vaginal dryness, and loss of libido. The Utian QoL improved significantly in the test group compared to the placebo group. No significant adverse events were recorded in the test group, suggesting the safety of this formulation. Conclusions The test compound could be a safe alternative to modern drugs. The findings of this study support the traditional use of Shatavari. Further clinical and pharmacological studies with longer duration and larger and more diverse sample sizes are required to understand the generalized effect of Shatavari root extract in menopausal women. Copyright © 2024, Gudise et al. DOI: 10.7759/cureus.57879 PMCID: PMC11079574 PMID: 38725785 Conflict of interest statement: The authors have declared that no competing interests exist.

Safety and efficacy of herbal extracts to restore respiratory health and improve innate immunity in COVID-19 positive patients with mild to moderate severity: A structured summary of a study protocol for a randomised controlled trial.

7. Trials. 2020 Nov 23;21(1):943. doi: 10.1186/s13063-020-04906-x. Safety and efficacy of herbal extracts to restore respiratory health and improve innate immunity in COVID-19 positive patients with mild to moderate severity: A structured summary of a study protocol for a randomised controlled trial. Rangnekar H(1), Patankar S(2), Suryawanshi K(3), Soni P(3). Author information: (1)Quest Clinicals and Ayurceuticals, Pune, India. h.rangnekar@questclinicalservices.co.in. (2)AMAI Charitable Trust, Pune, India. (3)YCM Hospital, Pune, India. OBJECTIVES: Primary Objective • To assess the efficacy of herbal extracts in boosting innate immunity of patients with COVID-19 infection. Secondary Objectives • To assess the efficacy of herbal extracts in restoring respiratory health • To assess the efficacy of Cap. IP in early recovery of patients and decline in viral load • To assess the safety of herbal extracts TRIAL DESIGN: This is a single centre, randomized, 2-arm, parallel group, double blind, 1:1 ratio, controlled, exploratory trial with a study period of 30 days from the day of enrolment. PARTICIPANTS: Patients attending the COVID treatment centre at Yashwantrao Chavan Memorial Hospital, Nehrunagar, Pimpri, Pune, India were screened for their participation in the study. Patients who were known COVID-19 positive (with positive RT-PCR), eligible and willing were enrolled in the study. INTERVENTION AND COMPARATOR: The intervention in the trial has a background in 'Ayurved'. Intervention Arm: Two capsules, Investigational Product (IP) - 1 - 400mg and Investigational Product - 2 - 450mg, containing herbal extracts (a blend of water and CO2 extracts) of Shunthi (Zingiber officinale (Ginger), Vidanga (Embelia ribes), Yashtimadhu (Glycyrrhiza glabra), Haritaki (Terminalia chebula), Guduchi (Tinospora cordifolia), Shatavari (Asparagus racemosus), Aamalaki (Emblica officinalis), Pippali (Piper longum) and calcined Zinc, Shankha bhasma. Placebo Arm: Edible starch ~ 450 mg. The look and feel of IP and of Placebo boxes were very similar. Patients are to take two capsules (one each of IP-1 and IP-2) twice a day for 15 days, and from the 16th day, one capsule of IP-2 twice a day up-to day 30. Capsules are to be administered orally with plain water. The IP is to be taken with all other concomitant medicines prescribed by the treating physician/doctor. The dose of each component in the IP is very safe to administer. The investigational products are registered products with the Indian Government and have been used for more than 6 months in various health conditions but not for COVID-19. MAIN OUTCOMES: Primary Outcome: Efficacy of the herbal extracts in COVID 19 positive patients (in declining viral load: time-point: 4 days and early recovery) Secondary Outcomes: Efficacy of the herbal extracts as an immune-modulator - TH1, TH2, Th17, IL6, NK Cells and CD markers; Immunoglobulin IGG (Serum); Immunoglobulin IGM (Serum) - at 30 days. Efficacy of the investigational product in reducing sequela of the disease Safety analysis (Liver Function Test and Kidney Function Test) including serious allergic reaction of: rash, itching/swelling, severe dizziness, trouble breathing. RANDOMISATION: An alphanumeric coded set of IP/Placebo containers will be used. Participants will be automatically randomized to two groups in the ratio 1:1. BLINDING (MASKING): Participants, caregivers and investigators were blinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of more than 60 and up to 75 patients were to be enrolled in the study into the two groups, considering drop-outs. 72 were enrolled with 37 into the intervention group and 35 into the placebo group. TRIAL STATUS: Protocol number: CoviQuest-01 Protocol version number: 1.2 Protocol Date: 1st July 2020 The recruitment period is completed for the trial. Date of 1st patient enrolment was 11th Aug 2020 and the last patient was enrolled on 3rd of September 2020. This is to state that it was a late submission from authors for publication of the protocol to the BMC, after enrolment in the study was over. Last Participant's last follow-up is scheduled on 5th October 2020 TRIAL REGISTRATION: The trial was prospectively registered with the CTRI (Clinical Trial Registry of India). Registration number is CTRI/2020/07/026570 . Registered on 14 July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. DOI: 10.1186/s13063-020-04906-x PMCID: PMC7680979 PMID: 33225970 [Indexed for MEDLINE] Conflict of interest statement: Dr. Suresh Patankar, who is one of the investigators is associated with the funding agency AMAI Charitable Trust, Pune. All other authors declare that they have no competing interests.

Systematic review of the efficacy of herbal galactogogues.

8. J Hum Lact. 2013 May;29(2):154-62. doi: 10.1177/0890334413477243. Epub 2013 Mar 6. Systematic review of the efficacy of herbal galactogogues. Mortel M(1), Mehta SD. Author information: (1)Division of Epidemiology and Biostatistics, University of Illinois at Chicago, IL, USA. mylove.mortel@uchospitals.edu Exclusive breastfeeding has been linked to many positive health outcomes, yet its widespread adoption as the primary mode of providing nutrition to infants remains challenging. The most common reported reason for early breastfeeding cessation is perception of inadequate milk production. To augment breast milk production, a substantial number of women turn to herbal galactogogues despite the limited scientific evidence of their efficacy and safety. We conducted a systematic review of published literature to evaluate the efficacy of herbal galactogogues. PubMed was searched from inception to October 2012 using an iterative search process that proceeded from broad categories to specific herbs. Manuscript references were also reviewed. Only experimental studies with objective outcome measures were included. Six trials met our search criteria. Using an adapted version of the CONSORT checklist, each trial was evaluated for potential sources of bias in design and reporting. Shatavari, torbangun, fenugreek, milk thistle, and a Japanese herbal medication were the 5 herbal preparations studied. Five trials found an increase in breast milk production. Several limitations exist that affect the validity of the trial results, including small sample size, insufficient randomization methods, poorly defined eligibility criteria, use of poly-herbal interventions, and variable breastfeeding practices among enrolled subjects. Given the insufficiency of evidence from these trials, no recommendation is made for the use of herbs as galactogogues. Well-designed and well-conducted clinical trials that address the above limitations are necessary to generate a body of evidence as a basis for recommendations regarding herbal galactogogues. DOI: 10.1177/0890334413477243 PMID: 23468043 [Indexed for MEDLINE]

Randomized controlled trial of Asparagus racemosus (Shatavari) as a lactogogue in lactational inadequacy.

9. Indian Pediatr. 1996 Aug;33(8):675-7. Randomized controlled trial of Asparagus racemosus (Shatavari) as a lactogogue in lactational inadequacy. Sharma S(1), Ramji S, Kumari S, Bapna JS. Author information: (1)Department of Pharmacology, Maulana Azad Medical College, New Delhi. PMID: 8979551 [Indexed for MEDLINE]