Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas
Status:
NOT_YET_RECRUITING
Trial end date:
2028-11-30
Target enrollment:
Participant gender:
Summary
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal AdenomasLRCRA.
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 /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.
Phase:
NA
Details
Lead Sponsor:
Jiangsu Famous Medical Technology Co., Ltd.
Collaborators:
Affiliated Hospital of Nanjing University of Chinese Medicine 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 Hospital of Shandong University Union Hospital, Tongji Medical College, Huazhong University of Science and Technology