Radicle GI Health RAATM: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Gastrointestinal-Related Quality of Life and Related Health Outcomes
Radicle Science
Summary
Radicle GI Health RAA: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on gastrointestinal-related quality of life and related health outcomes.
Description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, (2) currently experience persistent gas, bloating, indigestion, and/or irregular bowel movements for 3 months or more, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants that report a known contraindication or with well- established, significant safety concerns due to illness…
Eligibility
- Age range
- 21–105 years
- Sex
- All
- Healthy volunteers
- Yes
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 * Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed * 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 Exclusion Individuals who report any of the fo…
Interventions
- Dietary SupplementPlacebo GI Health Control
Participants will use their Placebo GI Health Control as directed for a period of 8 weeks
- Dietary SupplementActive GI Health Product 1
Participants will use their Active GI Health Product 1 as directed for a period of 8 weeks"
Location
- Radicle Science Inc.Del Mar, California