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Satavari and Ashoka for Menopause (SAM) Study
Sponsor: Vidya USA Corporation
Summary
This 12-week randomized, placebo-controlled clinical trial will evaluate the efficacy and safety of a daily oral supplement containing Ashoka Bark and Shatavari in women experiencing menopausal symptoms. Up to 50 participants will be randomized to receive either the active supplement or placebo, with 40 participants expected to complete the study. Participants will attend visits at Weeks 0, 6, and 12, where hormone levels (FSH and estradiol), menopausal symptoms, quality of life, anxiety, cognitive function, and sleep will be assessed using validated measures. The study will also explore changes in the vaginal microbiome and monitor safety and adherence throughout the trial. The study will be conducted at MusB Research in New Port Richey, Florida.
Official title: Shatavari & Ashoka for Menopause (SAM) Study
Key Details
Gender
FEMALE
Age Range
40 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-10-01
Completion Date
2026-12-15
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
Ashoka Bark and Shatavari
The intervention is an oral botanical dietary supplement containing Ashoka Bark (Saraca asoca) and Shatavari (Asparagus racemosus) intended for the management of menopausal symptoms. Participants will consume one capsule daily (100 mg) before or during a meal for 12 weeks. The formulation is being evaluated for its potential effects on menopausal symptom severity, hormone-related measures, quality of life, and related health outcomes in postmenopausal women. The intervention will be compared with a matched placebo under randomized, double-blind study conditions. Safety, adherence, and tolerability will be monitored throughout the study period.
Placebo
Matched placebo capsule containing inactive ingredients, administered orally once daily before or during a meal for 12 weeks. The placebo is identical in appearance to the active Ashoka Bark and Shatavari supplement to maintain blinding of participants, investigators, and outcome assessors. The placebo contains no active botanical ingredients and is used as the comparator to evaluate the effects of the Ashoka Bark and Shatavari intervention on menopausal symptoms and related outcomes.
Locations (1)
MusB Research LLC
New Port Richey, Florida, United States