Multi-center Randomized Controlled Clinical Study of Shenling Baishu Granule to Prevent the Recurrence of Low-risk Colorectal Adenoma
Shanghai Jiao Tong University School of Medicine
624 participants
Nov 24, 2025
INTERVENTIONAL
Conditions
Summary
1. Complete a large-sample, multicenter, randomized blank-controlled clinical trial to evaluate Shenling Baizhu Granules for the prevention of colorectal adenoma recurrence. 2. Generate high-level, internationally recognized clinical evidence to support the development of clinical practice guidelines for the prevention and treatment of colorectal adenoma using traditional Chinese medicine, and to strengthen the recommendation level of Shenling Baizhu Granules in clinical guidelines. 3. Define the clinical characteristics of patient subgroups most likely to benefit from Shenling Baizhu Granules for preventing colorectal adenoma recurrence.
Eligibility
Inclusion Criteria5
- 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.
- -70 years of age; any sex.
- Willing to participate and has voluntarily provided written informed consent.
Exclusion Criteria11
- 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.
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Interventions
Shenling Baizhu granules is a traditional Chinese medicine preparation in granular form. Participants in the experimental group will take 6 g orally three times daily for 6 months, initiated within 3 months after baseline endoscopic resection and health education. The granules should be taken before meals or at the same time as eating. The granules contain multiple Chinese herbs including Ginseng, Poria, Atractylodes macrocephala, and other traditional ingredients. This formulation is standardized according to Chinese pharmacopoeia standards and is manufactured under GMP conditions. This intervention is being tested for its ability to prevent the recurrence of low-risk colorectal adenomas after endoscopic resection.
Locations(1)
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NCT06930157