Shenling Baizhu Granule to prevent recurrence of low-risk colorectal adenoma.

Multi-center Randomized Controlled Clinical Study of Shenling Baishu Granule to Prevent the Recurrence of Low-risk Colorectal Adenoma

This will test whether taking Shenling Baizhu Granules for six months after polyp removal can reduce the chance that low-risk colorectal adenomas come back in adults aged 18–70.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 624 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06930157 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, open-label, randomized, blank-controlled trial enrolling adults with recently resected low-risk colorectal adenomas. All participants receive standard endoscopic minimally invasive polypectomy and health education, while the intervention group takes Shenling Baizhu Granules (6 g three times daily) for six months beginning within three months post-resection and the control group receives no granules. Participants are followed every six months for the first two years and once in the third year, with biospecimens (plasma, stool, tongue coating, saliva, tissue) and TCM syndrome assessments collected at baseline, month 6, and year 3. The study will compare adenoma recurrence rates and integrate clinical and biological data to define subgroups most likely to benefit.

Who should consider this trial

Good fit: Adults 18–70 years old who had complete endoscopic removal of low-risk colorectal adenomas within the past three months and can commit to follow-up and sample collection are ideal candidates.

Not a fit: Patients with incomplete adenoma resection, known hereditary polyposis or Lynch syndromes, active inflammatory bowel disease, recent malignancy, pregnancy or breastfeeding, or long-term use of aspirin/folic acid/calcium/vitamin D may not benefit or may be ineligible.

Why it matters

Potential benefit: If successful, this could offer an evidence-based, noninvasive herbal option to lower the risk of adenoma recurrence after polypectomy.

How similar studies have performed: Small single-center studies and traditional use suggest possible gastrointestinal protective effects of Shenling Baizhu and similar TCM formulas, but large multicenter randomized evidence for preventing adenoma recurrence is limited.

Eligibility criteria

Inclusion Criteria:

* Meets the diagnostic criteria for low-risk colorectal adenoma.
* Has undergone a colonoscopy of adequate quality (adequate bowel preparation, cecal intubation achieved, and withdrawal time ≥6 minutes) and received endoscopic minimally invasive polypectomy.
* Within 3 months after adenoma resection.
* 18-70 years of age; any sex.
* Willing to participate and has voluntarily provided written informed consent.

Exclusion Criteria:

* Incomplete adenoma resection.
* Long-term use of aspirin, folic acid, calcium supplements, vitamin D, or similar agents.
* Known hereditary polyposis syndromes (e.g., familial adenomatous polyposis) or hereditary colorectal cancer syndromes (e.g., Lynch syndrome/hereditary nonpolyposis colorectal cancer).
* Colonoscopy findings strongly suggestive of inflammatory bowel disease.
* History of malignancy within the past 5 years.
* Pregnant or breastfeeding women, or participants with pregnancy potential who are planning pregnancy.
* Severe cardiovascular or cerebrovascular disease, hepatic or renal insufficiency, or diabetes mellitus.
* Severe psychiatric disorders that would preclude cooperation with colonoscopy procedures.
* Current condition preventing oral administration of the study drug (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
* Participation in another clinical study within the past 3 months or current participation in another clinical study.
* Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

Where this trial is running

Shanghai, Shanghai Municipality

• Renji Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiaobo Li

Conditions Low-risk Colorectal Adenoma