drugset / Trial / NCT07129499
Shenbai Granules for Preventing Malignant Transformation of High-risk Colorectal Adenomas
Not yet recruiting
450 enrolled
Jiangsu Famous Medical Technology Co., Ltd.
Affiliated Hospital of Nanjing University of Chinese Medicine · collabChongqing Traditional Chinese Medicine Hospital · collabFirst Affiliated Hospital of Harbin Medical University · collabRenJi Hospital · collabShanxi Provincial People's Hospital · collabShengjing Hospital · collabShenzhen Hospital of Southern Medical University · collabSichuan Provincial People's Hospital · collabSixth Affiliated Hospital, Sun Yat-sen University · collabThe First Affiliated Hospital with Nanjing Medical University · collabThe Second Affiliated Hospital of Chongqing Medical University · collabThe Second Hospital of Shandong University · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2025-08-15
- Primary completion
- 2028-11-30
- Completion
- 2028-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Shenbai Granules | Traditional medicine (herbal / TCM) | 20 g | — |