Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas

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

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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Shenzhen Hospital of Southern Medical University

  collaborator OTHER

• Sixth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• Shanxi Provincial People's Hospital

  collaborator OTHER_GOV

• Affiliated Hospital of Nanjing University of Chinese Medicine

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Jiangsu Famous Medical Technology Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-15

Primary Completion

2028-11-30

Completion

2028-11-30

Countries

• China

Study Locations