Radicle Relief 1: A Study of Health and Wellness Products on Pain and Other Health Outcomes
NCT ID: NCT05589935
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
457 participants
INTERVENTIONAL
2022-11-22
2023-05-24
Brief Summary
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Detailed Description
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Eligible participants will (1) endorse a desire for less pain, (2) indicate an interest in taking a health and wellness product to potentially help relieve their pain, 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 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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Control 1
Relief Product Form 1 - control
Relief Study Product Usage
Participants instructed to use study product daily as directed for a period of 4 weeks
Active Product 1.1
Relief Product Form 1 - active product 1
Relief Study Product Usage
Participants instructed to use study product daily as directed for a period of 4 weeks
Interventions
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Relief Study Product Usage
Participants instructed to use study product daily as directed for a period of 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Resides in the United States
* Endorses pain as a primary issue (desire for less pain)
* Selects their desire for less pain 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
Exclusion Criteria
* Unable to provide a valid physical shipping address
* 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
* Lack of reliable daily access to the internet
* Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs
* 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-22D05
Identifier Type: -
Identifier Source: org_study_id