Radicle™ Health1: A Randomized, Blinded, Placebo-controlled Study of Health and Wellness Formulations and Their Effects on Overall Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,494
- 试验地点
- 2
- 主要终点
- Change in overall health-related quality of life
研究概览
简要总结
A randomized, blinded, placebo-controlled study of health and wellness product formulations and their effects on overall health
详细描述
This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for better health during screening; (2) indicate an interest in taking a health and wellness product to potentially help improve their health, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.
Self-reported data will be collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during 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
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 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21 years of age and older
- •Resides in the United States
- •Endorses: a desire for better sleep and/or focus, less pain, less feelings of stress, depression, and/or anxiety, and/or more energy (less fatigue)
- •Expresses a willingness to take a study product that may contain cannabinoids (or placebo) and not know the product identity until the end of the study
排除标准
- •Reports being pregnant, trying to become pregnant, or breastfeeding
- •Unable to provide a valid physical shipping address and mobile phone number
- •Reports a diagnosis of liver or kidney disease
- •Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- •Reports current enrollment in a clinical trial
- •The QOL score greater than 5 during enrollment
- •Unable to read and understand English
- •Lack of reliable daily access to the internet
- •Reports taking any medication that warns against grapefruit consumption
- •Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
结局指标
主要结局
Change in overall health-related quality of life
时间窗: 4 weeks
Mean difference in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr; scale 70-120; with higher scores corresponding to greater overall health across 7 health domains: physical function, ability to participate in social roles and activities, cognitive function, anxiety, depression, fatigue, sleep disturbance, pain interference and pain intensity)
次要结局
- Change in feelings of depression(4 weeks)
- Change in fatigue(4 weeks)
- Change in physical function(4 weeks)
- Change in feelings of anxiety(4 weeks)
- Change in sleep disturbance(4 weeks)
- Change in pain(4 weeks)
- Change in socialization ability(4 weeks)
- Minimal clinical importance difference (MCID) in overall health-related quality of life(4 weeks)
- Change in cognitive function(4 weeks)
- Change in libido(4 weeks)