Ignite Creation Date:
2024-05-06 @ 2:24 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04300855
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2020-03-05
Brief Title:
Clinical Trial of Green Tea Catechins in Men on Active Surveillance
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Clinical Trial of Green Tea Catechins in Men on Active Surveillance AS
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:
This randomized double-blinded Phase II clinical trial will evaluate the bioavailability safety effectiveness and validate the mechanism by which a standardized formulation of whole Green Tea Catechin Sunphenon 90D containing 405 mgs vs Placebo administered for 24 months in a cohort of men with low to intermediate grade prostate managed on active surveillance
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01CA235032-01A1 | NIH | None | httpsreporternihgovquickSearch1R01CA235032-01A1 |