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.
Provision of signed and dated informed consent form
Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
Baseline score of above-average menopause symptom levels on each of the patient reported scales: NRI-MSS (defined as 22+), the MRS scale (defined as 9+), AND 4+ on the MENQoL.
Confirmation of presence of hot flashes
Pregnant, trying to conceive, or breastfeeding
Hysterectomy, uterine ablation, or related procedure
Amenorrhea
Consumes > 8 alcoholic beverages in an average week
Parallel
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
Other interventionThe inert placebo does not contain any of the plant matter.
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.
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.
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.
Estriol
Laboratory test for estriol levels
Estradiol
Laboratory test for estradiol levels
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This trial is not recruiting at the moment. You can still explore other options:
