Menopausal Hot FlashesSupplementsNutrition and dietMenopauseWomen's healthDietary supplement
What this study is
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.
What's being tested
- ashwagandha root
Intervention · DIETARY SUPPLEMENT
This substance is extracted from the root of the plant.
- ashwagandha root and leaf
Intervention · DIETARY SUPPLEMENT
This substance is extracted from both the root and leaves of the plant.
- Placebo
Intervention · OTHER
The inert placebo does not contain any of the plant matter.
Study details
- Sponsor
- Nutraceuticals Research Institute
- Conditions
- Menopausal Hot Flashes · Menopausal Women
- Enrolling
- 90 people
- Starts
- 2025-10-01
- Est. completion
- 2026-03-30
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 55 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openNutraceuticals Research Institute
Huntsville, Alabama, United States
- Jessie Cavanaugh, PhD · Contact256-203-9010j.cavanaugh@nutraceuticalsresearch.com
Study team
Sponsor
Nutraceuticals Research Institute
Study ID 25-08-200
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.