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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Diagnosed with low-risk colorectal adenoma

• Complete colonoscopy examination (adequate bowel preparation, cecal intubation, withdrawal time \>6 minutes), with endoscopic resection performed including snare polypectomy, EMR, EPMR, ESD

• Within 1 month after adenoma resection

• Age 18-70 years

• Willing to provide written informed consent

Locations
Other Locations
China
Renji Hospital
RECRUITING
Shanghai
Contact Information
Primary
Xiaobo Li
lxb_1969@163.com
+86021-58752345
Time Frame
Start Date: 2025-11-21
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 624
Treatments
Experimental: Experimental Group (Shenling Baizhu Granules)
Participants will take Shenling Baizhu granules (6 grams, 3 times daily) for 6 months, along with basic health education.
No_intervention: Control Group (No intervention)
Participants will receive only basic health education without taking Shenling Baizhu granules.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov