Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorNutraceuticals Research Institute
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Pregnant, trying to conceive, or breastfeeding
Hysterectomy, uterine ablation, or related procedure
Amenorrhea
Consumes > 8 alcoholic beverages in an average week
Trial design
Treatments tested in this trial
- ashwagandha root
- ashwagandha root and leaf
- Placebo
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov