RecruitingPhase 4NCT06930157

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


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

624 participants

Start Date

Nov 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Shenling Baizhu granules (TCM patent medicine) for people with low-risk colorectal adenoma. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGShenling 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.


Locations(1)

Renji Hospital

Shanghai, Shanghai Municipality, China

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NCT06930157