Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-04 @ 8:48 AM
Study NCT ID:
NCT06930157
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Center Clinical Trial of Shenling Baizhu Granules for Preventing Low-Risk Colorectal Adenoma Recurrence
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Study Overview
Official Title:
A Multi-Center, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of Shenling Baizhu Granules in Preventing Recurrence of Low-Risk Colorectal Adenoma
Status:
RECRUITING
Status Verified Date:
2025-11
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:
The goal of this clinical trial is to learn if Shenling Baizhu granules can prevent colorectal adenoma from coming back in people who had low-risk colorectal adenomas removed. The main questions it aims to answer are:
* Can Shenling Baizhu granules lower the rate of colorectal adenoma returning after removal?
* How safe is Shenling Baizhu granules when used long-term for preventing adenoma?
* Which patients are most likely to benefit from this treatment?
Researchers will compare Shenling Baizhu granules to no treatment to see if the medicine works to prevent adenomas from returning.
Participants will:
* Take Shenling Baizhu granules (6 grams, 3 times daily) or receive no treatment for 6 months
* Have regular check-ups and provide blood, stool, saliva, and tissue samples
* Get a colonoscopy after 3 years to check if any adenomas have returned
* Fill out questionnaires about their symptoms and overall health throughout the study
This study will include 624 adults aged 18-70 who recently had low-risk colorectal adenomas removed at participating hospitals. The total study duration is 4 years.
* Can Shenling Baizhu granules lower the rate of colorectal adenoma returning after removal?
* How safe is Shenling Baizhu granules when used long-term for preventing adenoma?
* Which patients are most likely to benefit from this treatment?
Researchers will compare Shenling Baizhu granules to no treatment to see if the medicine works to prevent adenomas from returning.
Participants will:
* Take Shenling Baizhu granules (6 grams, 3 times daily) or receive no treatment for 6 months
* Have regular check-ups and provide blood, stool, saliva, and tissue samples
* Get a colonoscopy after 3 years to check if any adenomas have returned
* Fill out questionnaires about their symptoms and overall health throughout the study
This study will include 624 adults aged 18-70 who recently had low-risk colorectal adenomas removed at participating hospitals. The total study duration is 4 years.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: