The Effectiveness of a Proprietary Ashwagandha Extract on Menopausal Symptoms: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial
Nutraceuticals Research Institute
Summary
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.
Description
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.
Eligibility
- Age range
- 40–55 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Estridiol levels within the bottom 35% of normal ranges for their menstrual cycle phase (follicular/ovulation/luteal) as established by laboratory reference range * B…
Interventions
- Dietary Supplementashwagandha root
This substance is extracted from the root of the plant.
- Dietary Supplementashwagandha root and leaf
This substance is extracted from both the root and leaves of the plant.
- OtherPlacebo
The inert placebo does not contain any of the plant matter.
Location
- Nutraceuticals Research InstituteHuntsville, Alabama