Multi-Center Clinical Trial of Shenling Baizhu Granules for Preventing Low-Risk Colorectal Adenoma Recurrence

Phase 4

Not yet recruiting

• Conditions: Low-risk Colorectal Adenoma
• Interventions: Drug: Shenling Baizhu granules (TCM patent medicine)

• Registration Number: NCT06930157
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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 each year for 2 years

* 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

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-08
• Study First Posted: 2025-04-16
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Study Start: 2025-07-01
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 624

Inclusion Criteria

• 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

Exclusion Criteria

• Incomplete adenoma resection
• Long-term use of aspirin, folic acid, calcium, or vitamin D supplements
• Familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch syndrome), or other hereditary polyposis syndromes
• Severe inflammatory bowel disease
• History of malignancy within past 5 years (excluding basal cell carcinoma of the skin and/or cervical intraepithelial neoplasia after surgery)
• Pregnant or lactating women
• Severe cardiovascular disease, cerebrovascular disease, liver or kidney dysfunction, or diabetes
• Severe mental illness that prevents compliance with colonoscopy examination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group (Shenling Baizhu Granules)	Shenling Baizhu granules (TCM patent medicine)	Participants will take Shenling Baizhu granules (6 grams, 3 times daily) for 6 months each year for 2 years, along with basic health education.

Primary Outcome Measures

Name	Time	Method
Adenoma Recurrence Rate	At 3 years after enrollment	The proportion of participants with adenoma recurrence, compared between experimental and control groups, confirmed by colonoscopy

Secondary Outcome Measures

Name	Time	Method
Rate of Advanced Adenoma or Cancer Development	At 3 years after enrollment	The proportion of participants who develop advanced adenomas or colorectal cancer, comparing between experimental and control groups
TCM Syndrome Survey	At baseline, 6 months, 12 months, 18 months， 24 months and 36 months	The Traditional Chinese Medicine Syndrome Survey assesses bowel habits, abdominal symptoms, and secondary symptoms like oral discomfort and appetite, with scores ranging from 0 (no symptoms) to higher values indicating increasing severity, alongside tongue and pulse observations.