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.
Participants will take one of two extracts or a placebo every day for 84 days; outcomes of self-report menopausal symptoms collected on a trio of scales will provide information on effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
90
This substance is extracted from the root of the plant.
This substance is extracted from both the root and leaves of the plant.
The inert placebo does not contain any of the plant matter.
Nutraceuticals Research Institute
Huntsville, Alabama, United States
Proprietary Menopause Symptom Scale (NRI-MSS)
Nutraceuticals Research Institute's Menopause Symptom Scale is a validated self-report scale measuring symptoms across 6 domains. Scores range from 0-30, with higher scores indicating greater symptom severity.
Time frame: days 0, 28, 56, and 84
Menopause-Specific Quality of Life (MenQoL)
The MenQoL evaluates quality of life among menopausal women. Scores range from 0-8 with higher scores indicating greater symptom severity.
Time frame: days 0, 28, 56, and 84
Menopause Rating Scale (MRS)
The MRS is a self report assessment of menopausal symptoms with scores ranging from 0-44. Higher scores indicate greater symptom severity.
Time frame: Days 0, 28, 56, and 84
Estriol
Laboratory test for estriol levels
Time frame: days 0, 84
Estradiol
Laboratory test for estradiol levels
Time frame: days 0, 84
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