The Effectiveness of a Proprietary Ashwagandha Extract on Menopausal Symptoms: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Proprietary Menopause Symptom Scale (NRI-MSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Proprietary Menopause Symptom Scale (NRI-MSS)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Estriol(days 0, 84)
- Estradiol(days 0, 84)
研究者
Jessie Hawkins
Primary Investigator
Nutraceuticals Research Institute