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NOT YET RECRUITING
NCT07123116
NA

Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas

Sponsor: Jiangsu Famous Medical Technology Co., Ltd.

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2025-08-15

Completion Date

2028-11-30

Last Updated

2025-08-14

Healthy Volunteers

No

Interventions

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.

Locations (1)

Affiliated Hospital of Nanjing University of Chinese Medicine

Nanjing, Jiangsu, China