NCT07123116

Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas

Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas: A Multicenter Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Jiangsu Famous Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Adenoma
• TCM
• Low Risk

Interventions

Type	Name	Description
DRUG	Shenbai Granules	Dosage: bag 10g per , administered twice daily continuously for 180 days.
DRUG	Placebo	Dosage: 10g per bag, administered twice daily continuously for 180 days.

Timeline

• Start date: 2025-08-15
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: China