Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health
NCT ID: NCT05783232
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1494 participants
INTERVENTIONAL
2023-03-21
2023-10-27
Brief Summary
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Detailed Description
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Eligible participants will (1) endorse a desire for better health during screening; (2) indicate an interest in taking a health and wellness product to potentially help improve their health, 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 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Placebo Control 1 Capsules
Health Product Form 1 Capsules - control
Placebo Control Form 1 Capsules
Participants will use their Placebo Control Form 1 Capsules as directed for a period of 4 weeks.
Active Product 1.1 Capsules
Health Product Form 1 Capsules - active product 1
Health Active Study Product 1.1 Capsules
Participants will use their Radicle Health Active Study Product 1.1 Capsules as directed for a period of 4 weeks.
Active Product 1.2 Capsules
Health Product Form 1 Capsules - active product 2
Health Active Study Product 1.2 Capsules
Participants will use their Radicle Health Active Study Product 1.2 Capsules as directed for a period of 4 weeks.
Active Product 1.3 Capsules
Health Product Form 1 Capsules - active product 3
Health Active Study Product 1.3 Capsules
Participants will use their Radicle Health Active Study Product 1.3 Capsules as directed for a period of 4 weeks.
Interventions
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Placebo Control Form 1 Capsules
Participants will use their Placebo Control Form 1 Capsules as directed for a period of 4 weeks.
Health Active Study Product 1.1 Capsules
Participants will use their Radicle Health Active Study Product 1.1 Capsules as directed for a period of 4 weeks.
Health Active Study Product 1.2 Capsules
Participants will use their Radicle Health Active Study Product 1.2 Capsules as directed for a period of 4 weeks.
Health Active Study Product 1.3 Capsules
Participants will use their Radicle Health Active Study Product 1.3 Capsules as directed for a period of 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* Resides in the United States
* Endorses: a desire for better sleep and/or focus, less pain, less feelings of stress, depression, and/or anxiety, and/or more energy (less fatigue)
* Expresses a willingness to take a study product that may contain cannabinoids (or placebo) and not know the product identity until the end of the study
Exclusion Criteria
* Unable to provide a valid physical shipping address and mobile phone number
* Reports a diagnosis of liver or kidney disease
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Reports current enrollment in a clinical trial
* The QOL score greater than 5 during enrollment
* Unable to read and understand English
* Lack of reliable daily access to the internet
* Reports taking any medication that warns against grapefruit consumption
* Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
21 Years
105 Years
ALL
Yes
Sponsors
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Radicle Science
INDUSTRY
Responsible Party
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Principal Investigators
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Emily K. Pauli, PharmD
Role: PRINCIPAL_INVESTIGATOR
Radicle Science Inc.
Locations
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Radicle Science, Inc
Del Mar, California, United States
Countries
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Related Links
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Radicle Science, Inc
Other Identifiers
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RADX-22D07
Identifier Type: -
Identifier Source: org_study_id