NICEVIVA
MONOGRAPH SPEC LATEST 2026

Shatavari (Asparagus racemosus)

BOTANICALS · Evidence Monograph

Shatavari (Asparagus racemosus) is an evidence-graded botanicals monograph evaluated across 11 peer-reviewed PubMed studies (0 meta-analyses, 1 systematic reviews, and 6 randomized controlled trials, encompassing n = 3,309 cumulative participants). Current clinical evidence is rated GRADE Moderate (3.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) Moderate (3.0 / 4.0)
Indexed PubMed Studies 11 Studies
Meta-Analyses · Reviews 0 Meta · 1 Systematic Reviews
Randomized Trials (RCT) 6 RCTs (7 Double-Blind)
Cumulative Participants n = 3,309
Reported Trial Dosages 300 mg · 26,500 mg/day · 1 g
Trial Duration Range 12 weeks · 37 weeks · 60 days
Reading Time ~6 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 11 indexed PubMed studies, GRADE Moderate).
  2. 02 Adults matching clinical trial dosing protocols (300 mg · 26,500 mg/day · 1 g) over a structured 12 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary botanicals clinical efficacy (11 PubMed studies)
Quantitative biomarker & outcome analysis (8 studies with effect-size/sample data)
Randomized controlled trial verification (6 RCTs · 7 double-blind)
Systematic review & meta-analysis synthesis (0 meta-analyses · 1 reviews)
01

What Is Shatavari (Asparagus racemosus) & Why Does Form Matter?

Shatavari (Asparagus racemosus) is classified under BOTANICALS and has been investigated across 11 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (300 mg, 26,500 mg/day, 1 g).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Shatavari (Asparagus racemosus) frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (6 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Shatavari (Asparagus racemosus) acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Shatavari (Asparagus racemosus) an overall evidence rating of GRADE Moderate (3.0 / 4.0) based on 11 PubMed studies: 0 meta-analyses, 1 systematic reviews, and 6 randomized controlled trials (7 double-blind, n = 3,309 total participants).

Representative peer-reviewed findings include: • PMID:41816216 (2026) — "Efficacy and safety of Shatavari root extract in women with Polycystic Ovarian Syndrome: a randomized, double-blind, placebo-controlled trial." (CONCLUSION: Shatavari root extract oral administration can be a safe and effective potential intervention for women with PCOS.) • PMID:41055223 (2025) — "Shatavari (Asparagus racemosus Willd) root extract for postpartum lactation: A randomised, double-blind, placebo-controlled study." (CONCLUSION: Shatavari root extract improved the milk volume and maternal satisfaction about lactation, indicating its potential as a safe, effective galactagogue.) • PMID:38214710 (2024) — "Shatavari supplementation in postmenopausal women alters the skeletal muscle proteome and pathways involved in training adaptation." (CONCLUSION: Our analyses indicate that shatavari may support muscle adaptation responses to exercise.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 300 mg · 26,500 mg/day · 1 g · 1000 mg/day over 12 weeks · 37 weeks · 60 days · 30 days. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Shatavari (Asparagus racemosus), but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (300 mg · 26,500 mg/day · 1 g) and re-evaluate efficacy after 12 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (11 Studies) · 8 Quantitative Analyses

01
RANDOMIZED TRIAL (RCT) Frontiers in endocrinology (2026) PMID: 41816216 ↗
Efficacy and safety of Shatavari root extract in women with Polycystic Ovarian Syndrome: a randomized, double-blind, placebo-controlled trial.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Frontiers in endocrinology involving n = 35 participants; statistical significance reported at p = 0.254. Key conclusion: CONCLUSION: Shatavari root extract oral administration can be a safe and effective potential intervention for women with PCOS.
View Original PubMed Abstract ↓

BACKGROUND: Polycystic Ovarian Syndrome (PCOS) is a hormonal disorder affecting women of reproductive age. It frequently causes hormonal imbalance, irregular menstrual cycle, and in some cases, infertility. For centuries, traditional herbs like Shatavari (Asparagus racemosus Willd.) have been used to support women's reproductive health, and some studies suggest it may help with PCOS symptoms. Thus, this study aimed to evaluate the safety and efficacy of standardized Shatavari root extract in women with PCOS. METHODS: This prospective, randomized, double-blind, placebo-controlled trial was conducted on women aged 20-40 years for 12 weeks. Seventy participants were randomized into Shatavari root extract (SHT, n=35) and placebo (PL, n=35) groups. Sixty-six participants completed the full 12-week trial. The primary outcome was the change in ovarian and endometrial outcomes. Secondary outcomes were the change in Body Mass Index (BMI) and Perceived Stress Scale (PSS-10) scores. Assessments were performed at baseline, week 4, week 8, and week 12. Blood samples were collected at baseline and week 12 to estimate glycated hemoglobin (HbA1c), lipid profile, and serum insulin. The serum hormones, liver, renal, and thyroid functions were also assessed. For the safety assessment, adverse events were continuously monitored. RESULTS: Baseline demographics and clinical parameters were comparable between groups. At 12 weeks, Ovarian volume did not differ significantly between groups (p= 0.254). SHT significantly reduced psychological stress (PSS score: -6.64 ± 3.99; p < 0.0001), decreased follicular count (p < 0.0001), and increased endometrial thickness (p = 0.028) compared to PL. No significant differences were observed in BMI, hormonal levels, or laboratory parameters. No serious adverse events occurred; mild to moderate events were reported in 11.4% (SHT) and 8.5% (PL) of participants, all manageable with standard therapy and not related to the intervention. CONCLUSION: Shatavari root extract oral administration can be a safe and effective potential intervention for women with PCOS. The study was registered with the Clinical Trials Registry of India (CTRI) under registration

02
RANDOMIZED TRIAL (RCT) Journal of obstetrics and gynaecology (2025) PMID: 41055223 ↗
Shatavari (Asparagus racemosus Willd) root extract for postpartum lactation: A randomised, double-blind, placebo-controlled study.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Journal of obstetrics and gynaecology involving n = 113 participants; statistical significance reported at p = 0.002. Key conclusion: CONCLUSION: Shatavari root extract improved the milk volume and maternal satisfaction about lactation, indicating its potential as a safe, effective galactagogue.
View Original PubMed Abstract ↓

BACKGROUND: Inadequate milk production during the immediate postpartum period is a common problem. Shatavari (Asparagus racemosus), a revered herb in Ayurveda, is traditionally used as a galactagogue. The objective of this study is to assess the safety and effectiveness of Shatavari root extract (SHT) on lactation in post-partum women. METHODS: This prospective, randomised, double-blind, placebo-controlled study enrolled post-partum women (≥37 weeks' gestation, aged 20-40 years) with uncomplicated vaginal or caesarean deliveries who intended to breastfeed. Participants received either Shatavari root extract (SHT; 300 mg) or placebo (PL) capsules twice daily for 72 h postpartum. The primary outcomes included time to evident breast fullness after the last feeding and the total milk volume expressed at 72 h. The secondary outcomes were maternal and investigator-rated satisfaction (e.g. noticeable breast fullness, maternal/infant wellbeing), assessed by a five-point Likert scale. Safety was assessed through adverse event reports. RESULTS: From the 120 enrolled participants, seven participants (3 SHT, 4 PL) did not complete the study, yielding a per-protocol dataset of 113 women (57 SHT and 56 PL). The baseline characteristics were comparable across groups. The time to evident breast fullness after the last feeding was significantly shorter in the SHT group (p = 0.002), and milk volume at 72 h was significantly higher (p < 0.001). Maternal satisfaction with lactation was higher in the SHT group (52.63% vs. 25.00%, p = 0.008). SHT participants also reported greater satisfaction with infant well-being. Investigators rated maternal and infant well-being higher for SHT than placebo (80.70% vs. 64.29%). No adverse events occurred, and treatment compliance was high. CONCLUSION: Shatavari root extract improved the milk volume and maternal satisfaction about lactation, indicating its potential as a safe, effective galactagogue. Plain Language Summary: Breastfeeding is vital for both the mother and the baby. After childbirth, a few mothers might experience challenges with producing sufficient breast milk. The current study tested whether a natural herbal remedy called Shatav

03
CLINICAL STUDY European journal of nutrition (2024) PMID: 38214710 ↗
Shatavari supplementation in postmenopausal women alters the skeletal muscle proteome and pathways involved in training adaptation.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in European journal of nutrition. Key conclusion: CONCLUSION: Our analyses indicate that shatavari may support muscle adaptation responses to exercise.
View Original PubMed Abstract ↓

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).

04
CLINICAL STUDY Veterinary immunology and immunopathology (2023) PMID: 36801726 ↗
Evaluation of immunostimulatory attributes of Asparagus racemosus and Withania somnifera supplemented diets in fish, Channa punctatus (Bloch, 1793).
Clinical Trial Synthesis 2023 Clinical Study published in Veterinary immunology and immunopathology; statistical significance reported at p = 0.05. Key conclusion: 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.
View Original PubMed Abstract ↓

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 sco

05
CLINICAL STUDY Nutrients (2021) PMID: 34959836 ↗
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.
Clinical Trial Synthesis 2021 Randomized Controlled Trial (RCT) published in Nutrients involving n = 10 participants; statistical significance reported at p = 0.04. Key conclusion: 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.
View Original PubMed Abstract ↓

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.

06
CLINICAL STUDY The Cochrane database of systematic reviews (2020) PMID: 32421208 ↗
Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants.
Clinical Trial Synthesis 2020 Randomized Controlled Trial (RCT) published in The Cochrane database of systematic reviews involving n = 3,006 participants (MD 63.82). Key conclusion: OBJECTIVES: To assess the effect of oral galactagogues for increasing milk production in non-hospitalised breastfeeding mother-term infant pairs.
View Original PubMed Abstract ↓

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 th

07
RANDOMIZED TRIAL (RCT) Journal of the American Nutrition Association (2025) PMID: 40434025 ↗
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.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Journal of the American Nutrition Association; statistical significance reported at p = 0.001. Key conclusion: 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.
View Original PubMed Abstract ↓

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.

08
RANDOMIZED TRIAL (RCT) Cureus (2024) PMID: 38725785 ↗
Efficacy and Safety of Shatavari Root Extract for the Management of Menopausal Symptoms: A Double-Blind, Multicenter, Randomized Controlled Trial.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Cureus involving n = 70 participants. Key conclusion: Conclusions The test compound could be a safe alternative to modern drugs.
View Original PubMed Abstract ↓

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.

09
RANDOMIZED TRIAL (RCT) Trials (2020) PMID: 33225970 ↗
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.
Clinical Trial Synthesis 2020 Randomized Controlled Trial (RCT) published in Trials involving n = 75 participants. Key conclusion: MAIN OUTCOMES: Primary Outcome: Efficacy of the herbal extracts in COVID 19 positive patients (in declining viral load: time-point: 4
View Original PubMed Abstract ↓

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

10
SYSTEMATIC REVIEW Journal of human lactation (2013) PMID: 23468043 ↗
Systematic review of the efficacy of herbal galactogogues.
Clinical Trial Synthesis 2013 Systematic Review published in Journal of human lactation. Key conclusion: Five trials found an increase in breast milk production.
View Original PubMed Abstract ↓

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.

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