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

Completed · Not applicable · Has a placebo group

Conditions studied: Digestion, Abdominal Pain, GI Disorders

In brief

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal (GI) health and other health outcomes

Key facts

Study ID

NCT06009614

Run by

Radicle Science

People needed

2180

Starts

2023-08-15

Expected to finish

2024-02-20

Last updated by the study team

2024-05-20

Who can join

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

You may qualify if…

• Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
• 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

You may not qualify if…

• Reports being pregnant, trying to become pregnant, or breastfeeding
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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