Radicle™ Calm 1: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Feelings of Anxiety, Stress 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
- 1,211
- 试验地点
- 2
- 主要终点
- Change in feelings of anxiety
研究概览
简要总结
A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of health and wellness products on feelings of anxiety, stress and other health outcomes
详细描述
This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for less feelings of anxiety and/or stress, (2) indicate an interest in taking a health and wellness product to potentially improve their anxiety and/or stress, 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 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
- •Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
- •Resides in the United States
- •Endorses feelings of anxiety or stress as a primary issue (desire to reduce anxiety or less stress)
- •Selects feelings of anxiety/stress, looking to improve their feelings of anxiety/stress, and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product
- •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
- •Pregnant, trying to become pregnant, or breastfeeding
- •Unable to provide a valid physical shipping address
- •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
- •Lack of reliable daily access to the internet
- •Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs (monoamine oxidase inhibitors)
- •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 feelings of anxiety
时间窗: 4 weeks
Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)
次要结局
- Minimal clinically important difference (MCID) in stress(4 weeks)
- Change in cognitive function(4 weeks)
- Minimal clinically important difference (MCID) in anxiety(4 weeks)
- Change in stress(4 weeks)
- Change in sleep disturbance(4 weeks)