Ashoka Bark and Shatavari for Menopause
(SAM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for women going through menopause who are experiencing symptoms like hot flashes. Participants should be generally healthy and able to attend study visits over a 12-week period.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Ashoka Bark and Shatavari
Trial Overview
The study tests a daily oral supplement containing Ashoka Bark and Shatavari versus a placebo, to see if it helps with menopausal symptoms. Participants are randomly assigned to either group in this double-blind, controlled trial lasting 12 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants assigned to this arm will receive the active investigational supplement containing Ashoka Bark (Saraca asoca) and Shatavari (Asparagus racemosus). Participants will take one capsule daily (100 mg) orally before or during a meal for 12 weeks. The intervention is intended to evaluate the effect of the botanical formulation on menopausal symptoms, hormonal measures, quality of life, and exploratory microbiome outcomes. Participants will complete scheduled study assessments, symptom tracking, safety monitoring, and adherence evaluations throughout the intervention period.
Participants assigned to this arm will receive a matched placebo capsule administered orally once daily before or during a meal for 12 weeks. The placebo will be identical in appearance to the active supplement to maintain blinding. Participants will undergo the same clinical assessments, symptom evaluations, safety monitoring, and adherence assessments as the intervention arm to allow comparison of outcomes between groups.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vidya USA Corporation
Lead Sponsor
MusB Research
Industry Sponsor
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