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Recruiting
NCT05657808
Radicle Rest 2: A Study of Health and Wellness Products on Sleep and Health Outcomes
Conditions: Sleep, Sleep Disturbance, Sleep Disorder
Sex: All
Ages: 21 Years – 105 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 300
Sponsor: Radicle Science
Location: United States
Summary
A randomized, blinded, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sleep and other health outcomes.
Eligibility Criteria
Inclusion Criteria:Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identitiesResides in the United StatesEndorses better sleep as a primary desireSelects sleep, looking to improve their sleep, and/or reduce reliance on medications as a reason for their interest in taking a health and wellness productExpresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the studyExclusion Criteria:Reports being pregnant, trying to become pregnant, or breastfeedingUnable to provide a valid US shipping addressThe calculated validated health survey (PRO) measurement result is less than mild severity/impairmentReports a diagnosis of liver or kidney diseaseReports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)Unable to read and understand EnglishReports current enrollment in a clinical trialLack of reliable daily access to the internetReports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infectionReports 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
Source: ClinicalTrials.gov (NCT05657808). StuddyBuddy aggregates publicly available trial information.