Shenbai Granules for Preventing Malignant Transformation of High-risk Colorectal Adenomas

This multicenter, randomized, double-blind, placebo-controlled trial will enroll 450 patients with completely resected high-risk colorectal adenoma (HR-CRA), randomly assigned (1:1) to 6 months of Shenbai Granules (SBG) or placebo, followed for 3 years post-polypectomy. Primary endpoint: 3-year cumulative incidence of metachronous HR-CRA. Secondary endpoints: incidence, number, size, distribution, histology of low-risk adenomas and serrated lesions, and colorectal cancer occurrence.

NCT Number	NCT07129499
Lead Sponsor	Jiangsu Famous Medical Technology Co., Ltd. Collaborators: The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Harbin Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing Traditional Chinese Medicine Hospital, The Second Hospital of Shandong University, Shengjing Hospital, Shenzhen Hospital of Southern Medical University, Sixth Affiliated Hospital, Sun Yat-sen University, Sichuan Provincial People's Hospital, Shanxi Provincial People's Hospital, Affiliated Hospital of Nanjing University of Chinese Medicine, RenJi Hospital
Conditions	Colorectal Adenoma, High Risk, TCM
Enrollment	450 participants
Start Date	2025-08-15
Primary Completion	2028-11-30 (estimated)
Study Completion	2028-11-30 (estimated)
Updated on ClinicalTrials.gov	2025-08-19