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Ashwagandha for Menopausal Symptoms

This study is looking at how well two different ashwagandha extracts (ashwagandha root and ashwagandha root and leaf) work to reduce menopausal symptoms like hot flashes, compared to a placebo (an inactive substance). You may be able to join if you are a woman between 40 and 55 years old and have above-average menopausal symptoms. The researchers will know if the ashwagandha extracts are effective by measuring changes in your menopausal symptoms using three different questionnaires over 84 days. The current recruitment status for this study is unclear.

Study design
This is a randomized, double-blinded, placebo-controlled study, meaning participants are randomly assigned to receive one of the treatments or a placebo, and neither you nor your doctors will know which you are receiving. The study plans to enroll 90 participants.
What's involved
You would take either an ashwagandha extract or a placebo every day for 84 days. You would also complete self-report questionnaires about your menopausal symptoms on days 0, 28, 56, and 84.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be measured at days 0, 28, 56, and 84, which is the end of the study period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07210229

The Effectiveness of a Proprietary Ashwagandha Extract on Menopausal Symptoms: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial

Not Yet Recruiting
NAAges 40–55Interventional
Nutraceuticals Research Institute
~90 participants
Updated 2025-10-07 on ClinicalTrials.gov
What's tested:ashwagandha rootashwagandha root and leafPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proprietary Menopause Symptom Scale (NRI-MSS)
Measured over days 0, 28, 56, and 84
+2 more outcomes measured

Conditions

Menopausal Hot Flashes
Menopausal Women

Explore related trials

Menopause present

Where it's being run

1 sites across 1 states
Alabama1

Who to contact

Jessie Cavanaugh, PhD
[email protected]
256-203-9010
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Proprietary Menopause Symptom Scale (NRI-MSS)days 0, 28, 56, and 84

    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)days 0, 28, 56, and 84

    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)Days 0, 28, 56, and 84

    The MRS is a self report assessment of menopausal symptoms with scores ranging from 0-44. Higher scores indicate greater symptom severity.