Radicle Women's Health DNS™: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Women's Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 550
- 主要终点
- Change in fatigue
研究概览
简要总结
Radicle Women's Health DNSTM: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related women's health outcomes
详细描述
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) be women ages 21-60, (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 9 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
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
- Double (Participant, Investigator)
盲法说明
The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •3.1 Inclusion
- •Participants must meet all the following criteria:
- •Adult females, 21-60 years of age (inclusive) at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
- •Assigned sex at birth will determine sex-specific recruitment and PROs
- •Resides in the United States
- •Has the opportunity for at least 30% improvement in their primary health outcome
- •Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
- •3.2 Exclusion
- •Individuals who report any of the following during screening may be excluded from participation:
- •Report being pregnant, trying to become pregnant, or breastfeeding
- •Unable to provide a valid US shipping address and mobile phone number
- •Reports current enrollment in another clinical trial
- •Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- •Unable to read and understand English at a 7th grade level
- •Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
- •Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
- •NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
- •Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
- •Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
- •Reports current use of supplements with rhodiola root or maca root extract
- •Lack of reliable daily access to the internet
排除标准
- 未提供
结局指标
主要结局
Change in fatigue
时间窗: 9 weeks
Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
次要结局
- Change in sleep(9 weeks)
- Change in Pain Interference(9 weeks)
- Change in feelings of anxiety(9 weeks)
- Change in feelings of anger(9 weeks)
- Change in feelings of stress(9 weeks)