Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes

Completed · Not applicable · Has a placebo group

Conditions studied: Abdominal Pain, GI Disorders, Digestion

In brief

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes

Key facts

Study ID

NCT06376695

Run by

Radicle Science

People needed

4607

Starts

2024-04-29

Expected to finish

2025-06-05

Last updated by the study team

2025-10-02

Who can join

Age: 21 and older, up to 105. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
• Resides in the United States
• Endorses a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains
• 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

You may not qualify if…

• Report being pregnant, trying to become pregnant, or breastfeeding
• 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) that may limit the effects of the study product
• Lack of reliable daily access to the internet

Where it is running

• Radicle Science, Inc — Del Mar, California, United States

Full record on ClinicalTrials.gov

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