Radicle Rest 2: A Study of Health and Wellness Products on Sleep and Health Outcomes

Completed · Not applicable · Has a placebo group

Conditions studied: Sleep, Sleep Disturbance, Sleep Disorder

In brief

A randomized, blinded, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sleep and other health outcomes.

Key facts

Study ID

NCT05657808

Run by

Radicle Science

People needed

4152

Starts

2023-01-09

Expected to finish

2024-04-15

Last updated by the study team

2024-05-20

Who can join

Age: 21 and older, up to 105. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Radicle Science, Inc — Del Mar, California, United States

Full record on ClinicalTrials.gov

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