Phase
Condition
Ulcerative Colitis (Pediatric)
Dysmenorrhea (Painful Periods)
Colic
Treatment
Radicle GI Health Active Study Product 7.3.1 Usage
Radicle GI Health Active Study Product 5.1 Usage
Radicle GI Health Placebo Control Form 5
Clinical Study ID
Ages 21-105 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults, at least 21 years of age at the time of electronic consent, inclusive of allethnicities, races, and gender identities. Assigned sex at birth will determinesex-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 fewerstomach 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
Exclusion
Exclusion Criteria:
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 perday)
Unable to read and understand English
Reports a current and/or recent (up to 3 months ago) major illness and/or surgerythat poses a known, significant safety risk.
Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents aknown contraindication and/or a significant safety risk with any of the studyproduct ingredients. NYHA (New York Heart Association) Class Ill or IV congestiveheart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stageliver disease, stage 3b or 4 chronic kidney disease, or kidney failure
Reports taking medications that have a well-established moderate or severeinteraction, posing a substantial safety risk with any of the study productingredients. Anticoagulants, antihypertensives, anxiolytics, antidepressants,chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medicationsthat warn against grapefruit consumption, corticosteroids at doses greater than 5 mgper day, diabetic medications, oral anti-infectives (antibiotics, antifungals,antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidaseinhibitors), or thyroid products
Reports current use of the primary ingredient(s) and/or similar product(s) to theactive study product(s) that may limit the effects of the study product
Lack of reliable daily access to the internet
Study Design
Study Description
Connect with a study center
Radicle Science, Inc
Del Mar, California 92014
United StatesSite Not Available
Radicle Science, Inc
Del Mar 5342353, California 5332921 92014
United StatesSite Not Available
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