Radicle GI HealthTM VNB: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on constipation and related health outcomes
3.1 Inclusion
Participants must meet all the following criteria:
Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
Resides in the United States
Has the opportunity for at least 30% 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
3.2 Exclusion
Individuals who report any of the following during screening may be excluded from participation:
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 at a 7th grade level
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.
Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
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 products and/or pose a safety risk
Lack of reliable daily access to the internet
studymgmt@radiclescience.com858-779-0086
The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
Active GI Health Product 1
Placebo GI Health Control
susan.hewlings@radiclescience.com760-281-3898
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