Shenbai Granules for Preventing Malignant Transformation of High-risk Colorectal Adenomas

Summary

This multicenter, randomized, double-blind, placebo-controlled trial will enroll 450 patients with completely resected high-risk colorectal adenoma (HR-CRA), randomly assigned (1:1) to 6 months of Shenbai Granules (SBG) or placebo, followed for 3 years post-polypectomy. Primary endpoint: 3-year cumulative incidence of metachronous HR-CRA. Secondary endpoints: incidence, number, size, distribution, histology of low-risk adenomas and serrated lesions, and colorectal cancer occurrence.

Conditions

• Colorectal Adenoma
• High Risk
• TCM

Interventions

DRUG

Shenbai Granules

10 g/bag, two bags each time, twice a day, monthly for 30 days for 6 months.

DRUG

Placebo

10 g/bag, two bags each time, twice a day, monthly for 30 days for 6 months.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

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

  collaborator OTHER

• The Second Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Chongqing Traditional Chinese Medicine Hospital

  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

• RenJi Hospital

  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