NCT07230821

Radicle GI Health RDH™: A Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes

Radicle GI Health RDH™: 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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: Radicle Science · Industry
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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, and (2) 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 6 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Conditions

• Gas and Bloating
• Diarrhea
• Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	GI Health Active Product 1	Participants will use their GI Health Active Product 1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	GI Health Product Placebo Control	Participants will use their \[Product Name\] Control as directed for a period of 6 weeks

Timeline

• Start date: 2025-12-11
• Primary completion: 2026-12-11
• Completion: 2026-12-11
• First posted: 2025-11-17
• Last updated: 2025-11-17

Locations

1 site across 1 country: United States