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.
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.
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.
Parallel
Shenling Baizhu granules (TCM patent medicine)
DrugShenling 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.
Incidence of metachronous low-risk adenomas within 3 years after first dose
The incidence of metachronous low-risk adenomas will be calculated for each group as the number of participants with metachronous low-risk adenomas detected on surveillance colonoscopy within 3 years of enrollment divided by the total number of participants in that group.
Colorectal adenoma progression rate
The progression rate will be calculated for each group as the number of participants in whom colorectal adenoma progression (defined as high-risk adenoma and/or malignant transformation) is detected on surveillance colonoscopy within 3 years after enrollment divided by the total number of participants in that group.
TCM syndrome score
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.
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Shanghai Jiao Tong University School of Medicine
Lead sponsor
Affiliated Hospital of Nanjing University of Chinese Medicine
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborator
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Collaborator
Beijing Friendship Hospital
Collaborator
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
Collaborator
Institute of Science, Beijing Tongrentang Co., Ltd.
Collaborator
