Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376695
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-03-28
Brief Title:
Radicle GI Health 24 a Study of Health and Wellness Products on GI Health and Related Health Outcomes
Sponsor:
Radicle Science
Organization:
Radicle Science
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
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 double-blind placebo-controlled study assessing the impact of health and wellness products on 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 endorse a desire for improved bowel habits less bloatingindigestion andor fewer stomach achespains 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
Eligible participants will 1 endorse a desire for improved bowel habits less bloatingindigestion andor fewer stomach achespains 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 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