Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas
brief summary
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.
official title
Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas: A Multicenter Randomized Controlled Clinical Trial