Radicle Relaxation 24: A Study of Health and Wellness Products on Stress and Related Health Outcomes
NCT ID: NCT06378801
Last Updated: 2025-11-03
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
1700 participants
INTERVENTIONAL
2024-02-29
2024-11-01
Brief Summary
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Detailed Description
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Eligible participants will (1) endorse a desire for less stress (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Placebo Control 1
Relaxation Product Form 1 - control
Placebo Control Form 1
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Active Product 1.1
Relaxation Product Form 1 - active product 1
Relaxation Active Study Product 1.1
Participants will use their Radicle Relaxation Active Study Product 1.1 as directed for a period of 6 weeks.
Placebo Control 2
Relaxation Product Form 2 - control
Placebo Control Form 2
Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
Active Product 2.1
Relaxation Product Form 2 - active product 1
Relaxation Active Study Product 2.1
Participants will use their Radicle Relaxation Active Study Product 2.1 as directed for a period of 6 weeks.
Placebo Control 3
Relaxation Product Form 3 - control
Placebo Control Form 3
Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.
Active Product 3.1
Relaxation Product Form 3 - active product 1
Relaxation Active Study Product 3.1
Participants will use their Radicle Relaxation Active Study Product 3.1 as directed for a period of 6 weeks.
Placebo Control 4
Relaxation Product Form 4 - control
Placebo Control Form 4
Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.
Active Product 4.1
Relaxation Product Form 4 - active product 1
Relaxation Active Study Product 4.1
Participants will use their Radicle Relaxation Active Study Product 4.1 as directed for a period of 6 weeks.
Active Product 4.2
Relaxation Product Form 4 - active product 2
Relaxation Active Study Product 4.2
Participants will use their Radicle Relaxation Active Study Product 4.2 as directed for a period of 6 weeks.
Interventions
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Placebo Control Form 1
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Relaxation Active Study Product 1.1
Participants will use their Radicle Relaxation Active Study Product 1.1 as directed for a period of 6 weeks.
Placebo Control Form 2
Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
Relaxation Active Study Product 2.1
Participants will use their Radicle Relaxation Active Study Product 2.1 as directed for a period of 6 weeks.
Placebo Control Form 3
Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.
Relaxation Active Study Product 3.1
Participants will use their Radicle Relaxation Active Study Product 3.1 as directed for a period of 6 weeks.
Placebo Control Form 4
Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.
Relaxation Active Study Product 4.1
Participants will use their Radicle Relaxation Active Study Product 4.1 as directed for a period of 6 weeks.
Relaxation Active Study Product 4.2
Participants will use their Radicle Relaxation Active Study Product 4.2 as directed for a period of 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Resides in the United States
* Endorses less stress as a primary desire
* Has the opportunity for at least 20% improvement in their primary health outcome
* 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
* Unable to provide a valid US shipping address and mobile phone number
* Reports current enrollment in another clinical trial
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
* Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products
* Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s)
* Lack of reliable daily access to the internet
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-P-2408
Identifier Type: -
Identifier Source: org_study_id