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_SUPPLEMENT
    This substance is extracted from the root of the plant.
  • ashwagandha root and leaf — DIETARY_SUPPLEMENT
    This substance is extracted from both the root and leaves of the plant.
  • Placebo — OTHER
    The 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 1
    Participants in this arm will take an ashwagandha root supplement each day for 84 days.
  • Experimental: Plant Extract 2
    Participants in this arm will take an ashwagandha root and leaf supplement each day for 84 days.
  • Placebo Comparator: Placebo
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Nutraceuticals Research InstituteHuntsvilleAlabama35801
Jessie Cavanaugh, PhD
256-203-9010

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