Herbal hope for hot flashes: ashwagandha trial launches

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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