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Radicle™ Rest 2: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Sleep and Other Health Outcomes
A randomized, blinded, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sleep and other health outcomes.
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 improved sleep, (2) indicate an interest in taking a health and wellness product to potentially help their sleep, 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.
Age
21 - 105 years
Sex
ALL
Healthy Volunteers
Yes
Radicle Science, Inc
Del Mar, California, United States
Start Date
January 9, 2023
Primary Completion Date
December 4, 2023
Completion Date
April 15, 2024
Last Updated
May 20, 2024
4,152
ACTUAL participants
Rest Study Active Product 1.1 Usage
DIETARY_SUPPLEMENT
Rest Study Active Product 1.2 Usage
DIETARY_SUPPLEMENT
Rest Study Active Product 2.1 Usage
DIETARY_SUPPLEMENT
Rest Study Active Product 2.2 Usage
DIETARY_SUPPLEMENT
Placebo Control Form 1
DIETARY_SUPPLEMENT
Placebo Control Form 2
DIETARY_SUPPLEMENT
Placebo Control Form 3
DIETARY_SUPPLEMENT
Rest Study Active Product 3.1 Usage
DIETARY_SUPPLEMENT
Placebo Control Form 4
DIETARY_SUPPLEMENT
Rest Study Active Product 4.1 Usage
DIETARY_SUPPLEMENT
Rest Study Active Product 4.2 Usage
DIETARY_SUPPLEMENT
Rest Study Active Product 4.3 Usage
DIETARY_SUPPLEMENT
Lead Sponsor
Radicle Science
NCT01778504
NCT06430957
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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