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Multi-center Randomized Controlled Clinical Study of Shenling Baishu Granule to Prevent the Recurrence of Low-risk Colorectal Adenoma

NCT06930157 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2026-01-28

No results posted yet for this study

Summary

1. Complete a large-sample, multicenter, randomized blank-controlled clinical trial to evaluate Shenling Baizhu Granules for the prevention of colorectal adenoma recurrence.
2. Generate high-level, internationally recognized clinical evidence to support the development of clinical practice guidelines for the prevention and treatment of colorectal adenoma using traditional Chinese medicine, and to strengthen the recommendation level of Shenling Baizhu Granules in clinical guidelines.
3. Define the clinical characteristics of patient subgroups most likely to benefit from Shenling Baizhu Granules for preventing colorectal adenoma recurrence.

Conditions

  • Low-risk Colorectal Adenoma

Interventions

DRUG

Shenling Baizhu granules (TCM patent medicine)

Shenling Baizhu granules is a traditional Chinese medicine preparation in granular form. Participants in the experimental group will take 6 g orally three times daily for 6 months, initiated within 3 months after baseline endoscopic resection and health education. The granules should be taken before meals or at the same time as eating. The granules contain multiple Chinese herbs including Ginseng, Poria, Atractylodes macrocephala, and other traditional ingredients. This formulation is standardized according to Chinese pharmacopoeia standards and is manufactured under GMP conditions. This intervention is being tested for its ability to prevent the recurrence of low-risk colorectal adenomas after endoscopic resection.

Sponsors & Collaborators

  • Affiliated Hospital of Nanjing University of Chinese Medicine

    collaborator OTHER

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

    collaborator OTHER

  • Sixth Affiliated Hospital, Sun Yat-sen University

    collaborator OTHER

  • Shuguang Hospital of Shanghai University of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Beijing Friendship Hospital

    collaborator OTHER

  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

    collaborator UNKNOWN

  • Institute of Science, Beijing Tongrentang Co., Ltd.

    collaborator UNKNOWN

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06930157 on ClinicalTrials.gov