Status:
NOT_YET_RECRUITING
The Effectiveness of a Proprietary Ashwagandha Extract on Menopausal Symptoms: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial
Lead Sponsor:
Nutraceuticals Research Institute
Conditions:
Menopausal Hot Flashes
Menopausal Women
Eligibility:
FEMALE
40-55 years
Phase:
NA
Brief 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.
Detailed 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 Criteria
Inclusion
- 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
- Biological sex of female; gender identification of woman
- Aged 40 to 55, inclusive
- Good general health as evidenced by medical history and screening
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
- Still menstruating regularly (defined at least one period every 60 days)
- Agreement to adhere to Lifestyle Considerations throughout study duration
Exclusion
- Pregnant, trying to conceive, or breastfeeding
- Hysterectomy, uterine ablation, or related procedure
- Amenorrhea
- Consumes \> 8 alcoholic beverages in an average week
- Currently consumes an ashwagandha supplement or has consumed one regularly (defined as 1x week or more often) within the past 24 months
- Consumes any hormonal therapies or menopause-related supplements intended to improve symptoms in any way
- Current or recent (within 60 days) history of taking thyroid medications, hypertensive drugs, CNS depressants, diabetic medications, benzodiazepines, or immunosuppressants
- Any liver, kidney, hormonal, or cardiovascular disorder
- Known allergic reactions to any components of the intervention
- Recent dramatic weight changes (10% change in body weight in the last 6 months)
- Introducing a new investigational drug or other intervention within 60 days before the start of the study
- Any change to diet or lifestyle within 60 days before the start of the study (defined as introducing any new exercise activity, joining a gym, starting a new routine, moving to a new home, adjusting dietary habits (e.g. vegetarian, paleo, etc) or discontinuing any habits or diets.
- Any health or medical condition which, in the primary investigators opinion, may interfere with the conduct of the study
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07210229
Start Date
October 1 2025
End Date
March 30 2026
Last Update
October 7 2025
Active Locations (1)
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1
Nutraceuticals Research Institute
Huntsville, Alabama, United States, 35801