Abstract / Summary
High-risk colorectal adenomas (HR-CRAs) are a recognized precursor lesion for colorectal cancer, with 25–40% of patients developing metachronous adenomas within 3 years after endoscopic resection. Low-dose aspirin is the only agent supported by high-level evidence for reducing the incidence of metachronous HR-CRAs, but its use is limited by bleeding risks. Previous studies on the traditional Chinese medicine compound Shenbai Granules (SBG) have suggested its potential in preventing metachronous HR-CRAs, sufficient evidence from randomised controlled trials are still lacking. This trial aims to evaluate the efficacy and safety of SBG in preventing the development of metachronous adenomas and subsequent carcinogenesis, and to identify clinical predictors of treatment response to define the optimal target population. This multicentre, randomised, double-blind, placebo-controlled trial will enroll 450 patients with endoscopically resected HR-CRAs. Participants will be randomly allocated 1:1 to receive either SBG ( n = 225) or a matching placebo ( n = 225). The trial comprises a 14-day screening period, a 6-month treatment phase, and a 30-month surveillance phase, including four on-site visits and one telephone follow-up. This study adopts a superiority design. The primary outcome is the detection rate of metachronous HR-RCAs within 3 years after the initial administration. Secondary outcomes include the detection rate of metachronous low-risk CRAs and serrated lesions, as well as their cumulative number of detection episodes, total lesion count, size, distribution, anatomic location, pathological characteristics, and the incidence of colorectal cancer within 3 years after the first dose. This trial’s outcomes may establish objective clinical evidences supporting SBG’s therapeutic benefits and safety in preventing malignant transformation of high-risk colorectal adenomas. This trial is registered in ClinicalTrials.gov (ID NCT07129499) on August 18, 2025.