About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Shenling Baizhu granules (TCM patent medicine)
Treatment groups
Sponsors and collaborators
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