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

Shanghai Jiao Tong University School of Medicine

Status and phase

Begins enrollment this month

Phase 4

Conditions

Low-risk Colorectal Adenoma

Treatments

Drug: Shenling Baizhu granules (TCM patent medicine)

Study type

Interventional

Funder types

Other

Identifiers

NCT06930157

KY2024-191-C

Details and patient eligibility

About

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.

Enrollment

624 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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