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

Abdominal Pain Clinical Trial

Official title:
Radicle GI Health™ 24: A Randomized, Double-Blind, Placebo-Controlled, Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes

Clinical Trial Summary

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

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) endorse a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06376695
Study type Interventional
Source Radicle Science
Contact
Status Active, not recruiting
Phase N/A
Start date March 19, 2024
Completion date October 2024
View Details
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