Menopausal Hot Flashes, Menopausal Women
Conditions
Keywords
ashwagandha
Brief summary
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_SUPPLEMENTashwagandha root
This substance is extracted from the root of the plant.
DIETARY_SUPPLEMENTashwagandha root and leaf
This substance is extracted from both the root and leaves of the plant.
OTHERPlacebo
The inert placebo does not contain any of the plant matter.
Sponsors
Nutraceuticals Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estriol | days 0, 84 | Laboratory test for estriol levels |
| Estradiol | days 0, 84 | Laboratory test for estradiol levels |
Countries
United States
Contacts
Primary ContactJessie Cavanaugh, PhD
Outcome results
None listed