The Effectiveness of a Proprietary Ashwagandha Extract on Menopausal Symptoms: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial
Part of paid clinical trials in Huntsville, Alabama.
- Sponsor
- Nutraceuticals Research Institute
- Study ID
- NCT07210229
- Status
- Not Yet Recruiting
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Conditions
- Menopausal Hot Flashes
- Menopausal Women
Eligibility Criteria
- Sex
- FEMALE
- Age
- 40 Years - 55 Years
- Healthy Volunteers
- Not accepted
Interventions
- ashwagandha root — DIETARY_SUPPLEMENTThis substance is extracted from the root of the plant.
- ashwagandha root and leaf — DIETARY_SUPPLEMENTThis substance is extracted from both the root and leaves of the plant.
- Placebo — OTHERThe inert placebo does not contain any of the plant matter.
Study Details
The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on symptoms of menopause and hormone levels, as compared to a placebo.
Key Dates
- Start date
- Oct 1, 2025
- Status verified
- Aug 2025
- Primary completion
- Feb 28, 2026
- Completion
- Mar 30, 2026
Study Design
- Enrollment
- 90 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Plant Extract 1Participants in this arm will take an ashwagandha root supplement each day for 84 days.
- Experimental: Plant Extract 2Participants in this arm will take an ashwagandha root and leaf supplement each day for 84 days.
- Placebo Comparator: PlaceboParticipants in this arm will take an inert placebo each day for 84 days.
Primary Outcome Measure
Proprietary Menopause Symptom Scale (NRI-MSS) [ Time Frame: days 0, 28, 56, and 84 ]
Central Contacts
- Jessie Cavanaugh, PhD256-203-9010
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Nutraceuticals Research Institute | Huntsville | Alabama | 35801 |
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