Satavari and Ashoka for Menopause (SAM) Study

Part of paid clinical trials in New Port Richey, Florida.

Sponsor
Vidya USA Corporation
Study ID
NCT07861295
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ashoka Bark and Shatavari — DIETARY_SUPPLEMENT
    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 — OTHER
    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.

Study Details

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.

Key Dates

First listed
Oct 6, 2026
Start date
Oct 1, 2025
Status verified
Sep 2026
Primary completion
Dec 1, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ashoka Bark and Shatavari Intervention Arm
    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.
  • Placebo Comparator: Placebo Control Arm
    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.

Primary Outcome Measure

Change in Menopausal Rating Scale total score [ Time Frame: Baseline (Day 0) to Week 12 (Day 84) ]

Locations (1)

FacilityCityStateZIPSite coordinators
MusB Research LLCNew Port RicheyFlorida34653
Prinicipal Investigator
[email protected]
8134190781

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By condition
Menopause
By specialty
Women's healthFertility
By research site
MusB Research LLC· New Port Richey, FL

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