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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Jiao Tong University School of Medicine

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

624 Participants
are divided into 2 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