The Effectiveness of a Proprietary Ashwagandha Extract on Stress Reduction: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Post-test Cortisol Awakening Response, after controlling for baseline scores
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on stress levels, with secondary outcomes of cognition, energy, and sleep, as compared to a placebo.
详细描述
Participants will take one of two extracts or a placebo every day for 60 days; outcomes of stress, sleep, energy, and cognition 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, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
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
- •Self reported high stress
- •Baseline score of above-average stress levels on the NRI-SS
- •Biological sex of woman; gender identification of female
- •Aged 30 to 59, 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
- •Agreement to adhere to Lifestyle Considerations throughout study duration
排除标准
- •Pregnancy, trying to conceive, or breastfeeding
- •Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year
- •Consumes > 8 alcoholic beverages in an average week
- •Is a primary caretaker for a child younger than 18 months of age
- •Currently consumes an ashwagandha supplement or has consumed one regularly (defined as 1x week or more often) within the past 24 months
- •Consumes any stress aid, medication, diet, or supplement intended to improve stress 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 or kidney disorder
- •Known allergic reactions to any components of the intervention
- •Positive COVID-19 test within 30 days of the study period
- •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
- •Introducing a new lifestyle stress-reduction aid (i.e. physical activity, yoga, etc) within 60 days before the start of the study
结局指标
主要结局
Post-test Cortisol Awakening Response, after controlling for baseline scores
时间窗: 60 days
salivary cortisol levels will be taken immediately after waking and 30 minutes later to produce a composite score
NRI-SS (Nutraceuticals Research Institute's Stress Scale)
时间窗: 60 days
This is a validated scale measuring 6 subdomains of stress. It is measured on a likert scale. Scores on each subdomain can range from 5 to 42, with higher scores indicating greater stress levels.
次要结局
- NRI-ES (Nutraceuticals Research Institute's Energy Scale)(60 days)
- NRI-Sleep (Nutraceuticals Research Institute's Sleep Scale)(60 days)
- NRI-Cognition Scale(60 days)
研究者
Jessie Hawkins
PhD
Nutraceuticals Research Institute