Shenbai Granules for Preventing Malignant Transformation of High-risk Colorectal Adenomas
Status:
NOT_YET_RECRUITING
Trial end date:
2028-11-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
NA
Details
Lead Sponsor:
Jiangsu Famous Medical Technology Co., Ltd.
Collaborators:
Affiliated Hospital of Nanjing University of Chinese Medicine Chongqing Traditional Chinese Medicine Hospital First Affiliated Hospital of Harbin Medical University RenJi Hospital Shanxi Provincial People's Hospital Shengjing Hospital Shenzhen Hospital of Southern Medical University Sichuan Provincial People's Hospital Sixth Affiliated Hospital, Sun Yat-sen University The First Affiliated Hospital with Nanjing Medical University The Second Affiliated Hospital of Chongqing Medical University The Second Hospital of Shandong University Union Hospital, Tongji Medical College, Huazhong University of Science and Technology