Radicle™ GI Health: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Gastrointestinal (GI) Health and Other Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,180
- 试验地点
- 2
- 主要终点
- Change in GI (Gastrointestinal) - related Quality of Life (QOL)
研究概览
简要总结
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal (GI) health and other health outcomes
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 less bloating or indigestion, (2) indicate an interest in taking a health and wellness product to potentially help their bloating or indigestion, 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 are collected electronically from eligible participants over 7 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
- •Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
- •Resides in the United States
- •Endorses less bloating or indigestion as a primary desire
- •Has the opportunity for at least 20% improvement in their primary health outcome score
- •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
- •Reports being pregnant, trying to become pregnant, or breastfeeding
- •Unable to provide a valid US shipping address and mobile phone number
- •The calculated validated health survey (PRO) score during enrollment represents less than mild severity
- •Reports a diagnosis of liver or kidney disease
- •Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- •Unable to read and understand English
- •Reports current enrollment in another clinical trial
- •Lack of reliable daily access to the internet
- •Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
- •Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products
- •Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHAA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
结局指标
主要结局
Change in GI (Gastrointestinal) - related Quality of Life (QOL)
时间窗: 6 weeks
Mean difference in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)
次要结局
- Change in gas/bloating(6 weeks)
- Minimal clinically important difference (MCID) in gas/bloating(6 weeks)
- Minimal clinically important difference (MCID) in GI-related QOL(6 weeks)
- Minimal clinically important difference (MCID) in abdominal pain(6 weeks)
- Change in abdominal pain(6 weeks)
- Change in feelings of anxiety(6 weeks)