Radicle Rest™ 24: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Sleep and Related Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,646
- 试验地点
- 2
- 主要终点
- Change in sleep
研究概览
简要总结
A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sleep and related 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) endorse a desire for better sleep, (2) have the opportunity for meaningful improvement (at least 20%) 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 cardiac dysfunction, liver or kidney disease may be excluded. 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 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. 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
Participants will be stratified based on gender at birth then randomized to one of the study arms
入排标准
- 年龄范围
- 21 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
- •Resides in the United States
- •Endorses better sleep as a primary desire
- •Has the opportunity for at least 20% 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
排除标准
- •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
- •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 (New York Heart Association) Class Ill 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, antihypertensive, 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, MAOls (monoamine oxidase inhibitors), or thyroid products
- •Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products
- •Lack of reliable daily access to the internet
结局指标
主要结局
Change in sleep
时间窗: 6 weeks
Mean difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)
次要结局
- Change in fatigue(6 weeks)
- Change in mood (emotional distress-depression)(6 weeks)
- Minimal clinically important difference (MCID) in sleep(6 weeks)
- Minimal clinically important difference (MCID) in fatigue(6 weeks)
- Minimal clinically important difference (MCID) in mood (emotional distress-depression)(6 weeks)
- Minimal clinically important difference (MCID) in feelings of anxiety(6 weeks)
- Change in feelings of anxiety(6 weeks)