drugset / Trial / NCT06930157
Multi-center Randomized Controlled Clinical Study of Shenling Baishu Granule to Prevent the Recurrence of Low-risk Colorectal Adenoma
Phase 4
Recruiting
624 enrolled
Shanghai Jiao Tong University School of Medicine
Affiliated Hospital of Nanjing University of Chinese Medicine · collabBeijing Friendship Hospital · collabInstitute of Science, Beijing Tongrentang Co., Ltd. · collabShuguang Hospital of Shanghai University of Traditional Chinese Medicine · collabSixth Affiliated Hospital, Sun Yat-sen University · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabYueyang Hospital of Integrated Traditional Chinese and Western Medicine · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2025-11-24
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Shenling Baizhu granules | Traditional medicine (herbal / TCM) | 6 g | Oral |