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Not yet recruiting NCT07210229

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

No phase Interventional Menopausal Hot Flashes Menopausal Women

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ashwagandha root, ashwagandha root and leaf, Placebo.
Who it may be relevant to
Registry conditions: Menopausal Hot Flashes, Menopausal Women. Basic parameters: 40 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Dietary supplement ashwagandha root
    This substance is extracted from the root of the plant.
  • Dietary supplement ashwagandha root and leaf
    This substance is extracted from both the root and leaves of the plant.
  • Other Placebo
    The inert placebo does not contain any of the plant matter.

Primary outcome measures

  • Proprietary Menopause Symptom Scale (NRI-MSS) [Time frame: days 0, 28, 56, and 84]
  • Menopause-Specific Quality of Life (MenQoL) [Time frame: days 0, 28, 56, and 84]
  • Menopause Rating Scale (MRS) [Time frame: Days 0, 28, 56, and 84]
Secondary outcome measures (2)
  • Estriol [Time frame: days 0, 84]
  • Estradiol [Time frame: days 0, 84]

Eligibility criteria

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
  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Nutraceuticals Research Institute — Huntsville

Identifiers

NCT: NCT07210229 · 25-08-200

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗