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

Abdominal Pain Clinical Trial

Official title:
Radicle™ GI Health: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Gastrointestinal (GI) Health and Other Health Outcomes

Clinical Trial Summary

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

Clinical Trial Description

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for less bloating or indigestion, (2) indicate an interest in taking a health and wellness product to potentially help their bloating or indigestion, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded. Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during 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 NCT06009614
Study type Interventional
Source Radicle Science
Contact
Status Completed
Phase N/A
Start date August 15, 2023
Completion date February 20, 2024
View Details
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