Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas（LRCRA）. Study Population: Post-resection patients with low-risk colorectal adenomas and Spleen Deficiency with Dampness-Heat Syndrome per TCM criteria. Sample Size: 450 subjects (1:1 randomization; 225 per arm) accounting for ≤20% dropout. Study Hypothesis (Exploratory) ： This exploratory trial aims to evaluate the potential efficacy and safety of Shenbai Granules, a TCM formula, in reducing LRCRA recurrence. Based on preliminary data suggesting a 32.64% relative risk reduction in LRCRA recurrence at 2 years, we hypothesize that Shenbai Granules may demonstrate clinically meaningful prevention of adenoma recurrence and offer a favorable safety profile in the target TCM syndrome population. No formal statistical hypothesis is tested. Statistical Analysis Analysis Sets: mITT (primary efficacy), PPS, SS (safety). Primary Analysis: Proportion difference (Newcombe method) and χ²/Fisher's exact test (stratified CMH if applicable). Sensitivity analyses: PPS, tipping-point imputation for missing data. Safety: Descriptive summaries of AEs/SAEs (MedDRA-coded), lab abnormalities.

NCT Number	NCT07123116
Lead Sponsor	Jiangsu Famous Medical Technology Co., Ltd. Collaborators: The First Affiliated Hospital with Nanjing Medical University, 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, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions	Colorectal Adenoma, TCM, Low Risk
Enrollment	450 participants
Start Date	2025-08-15
Primary Completion	2028-11-30 (estimated)
Study Completion	2028-11-30 (estimated)
Updated on ClinicalTrials.gov	2025-08-14