Sleep Clinical Trial
Official title:
Radicle™ Rest 2: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Sleep and Other Health Outcomes
Verified date | May 2024 |
Source | Radicle Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized, blinded, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sleep and other health outcomes.
Status | Completed |
Enrollment | 4152 |
Est. completion date | April 15, 2024 |
Est. primary completion date | December 4, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 105 Years |
Eligibility | Inclusion Criteria: - 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 better sleep as a primary desire - Selects sleep, looking to improve their sleep, 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 Exclusion Criteria: - Reports being pregnant, trying to become pregnant, or breastfeeding - Unable to provide a valid US shipping address - The calculated validated health survey (PRO) measurement result is less than mild severity/impairment - 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 a clinical trial - Lack of reliable daily access to the internet - Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection - Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied: anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or monoamine oxidase inhibitors (MAOIs) - Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: New York Heart Association (NYHA) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias |
Country | Name | City | State |
---|---|---|---|
United States | Radicle Science, Inc | Del Mar | California |
Lead Sponsor | Collaborator |
---|---|
Radicle Science |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in sleep disturbance | Mean difference in sleep disturbance 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) | 6 weeks | |
Secondary | Change in fatigue | Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue) | 6 weeks | |
Secondary | Change in cognitive function | Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where higher scores correspond to greater cognitive function) | 6 weeks | |
Secondary | Change in anxiety | Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) | 6 weeks | |
Secondary | Change in mood (emotional distress) | Mean difference in mood score as assessed by PROMIS Depression 4A (scale 4-20; where higher scores correspond to more severe depression) | 6 weeks | |
Secondary | Change in libido | Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where higher scores correspond to greater sexual interest) | 6 weeks | |
Secondary | Minimal clinical importance difference (MCID) in sleep disturbance | Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance) | 6 weeks |
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