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

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

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.

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