Radicle GI Health: A Study of Health and Wellness Products on GI Health and Other Health Outcomes
NCT ID: NCT06009614
Last Updated: 2024-05-20
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
2180 participants
INTERVENTIONAL
2023-08-15
2024-02-20
Brief Summary
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Detailed Description
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Eligible participants will (1) endorse a desire for less bloating or indigestion, (2) indicate an interest in taking a health and wellness product to potentially help their bloating or indigestion, 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Placebo Control 1
GI Health Product Form 1 - control
Radicle GI Health Placebo Control Form 1
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Active Product 1.1
GI Health Product Form 1 - active product 1
Radicle GI Health Active Study Product 1.1 Usage
Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.
Placebo Control 2
GI Health Product Form 2 - control
Radicle GI Health Placebo Control Form 2
Participants will use their Radicle GI Health Placebo Control Form 2 as directed for a period of 6 weeks.
Active Product 2.1
GI Health Product Form 2 - active product 1
Radicle GI Health Active Study Product 2.1 Usage
Participants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks.
Active Product 2.2
GI Health Product Form 2 - active product 2
Radicle GI Health Active Study Product 2.2 Usage
Participants will use their Radicle GI Health Active Study Product 2.2 as directed for a period of 6 weeks.
Placebo Control 3
GI Health Product Form 3 - control
Radicle GI Health Placebo Control Form 3
Participants will use their Radicle GI Health Placebo Control Form 3 as directed for a period of 6 weeks.
Active Product 3.1
GI Health Product Form 3 - active product 1
Radicle GI Health Active Study Product 3.1 Usage
Participants will use their Radicle GI Health Active Study Product 3.1 as directed for a period of 6 weeks.
Interventions
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Radicle GI Health Placebo Control Form 1
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Radicle GI Health Active Study Product 1.1 Usage
Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.
Radicle GI Health Placebo Control Form 2
Participants will use their Radicle GI Health Placebo Control Form 2 as directed for a period of 6 weeks.
Radicle GI Health Active Study Product 2.1 Usage
Participants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks.
Radicle GI Health Active Study Product 2.2 Usage
Participants will use their Radicle GI Health Active Study Product 2.2 as directed for a period of 6 weeks.
Radicle GI Health Placebo Control Form 3
Participants will use their Radicle GI Health Placebo Control Form 3 as directed for a period of 6 weeks.
Radicle GI Health Active Study Product 3.1 Usage
Participants will use their Radicle GI Health Active Study Product 3.1 as directed for a period of 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Resides in the United States
* Endorses less bloating or indigestion as a primary desire
* Has the opportunity for at least 20% improvement in their primary health outcome score
* 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
* The calculated validated health survey (PRO) score during enrollment represents less than mild severity
* 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 another clinical trial
* Lack of reliable daily access to the internet
* Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
* Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products
* Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHAA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
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-2307
Identifier Type: -
Identifier Source: org_study_id
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