Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06009614
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2023-08-18
Brief Title:
Radicle GI Health A Study of Health and Wellness Products on GI Health and Other Health Outcomes
Sponsor:
Radicle Science
Organization:
Radicle Science
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized blinded placebo-controlled study assessing the impact of health and wellness products on gastrointestinal GI health and other health outcomes
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None