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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Meets the diagnostic criteria for low-risk colorectal adenoma.

• Has undergone a colonoscopy of adequate quality (adequate bowel preparation, cecal intubation achieved, and withdrawal time ≥6 minutes) and received endoscopic minimally invasive polypectomy.

• Within 3 months after adenoma resection.

• 18-70 years of age; any sex.

• Willing to participate and has voluntarily provided written informed consent.

Locations
Other Locations
China
Renji Hospital
RECRUITING
Shanghai
Contact Information
Primary
Xiaobo Li
lxb_1969@163.com
+86021-58752345
Time Frame
Start Date: 2025-11-24
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 624
Treatments
Experimental: Experimental Group (Shenling Baizhu Granules)
Participants will take Shenling Baizhu granules (6 g, three times daily) for 6 months, started within 3 months after standard endoscopic treatment, in addition to basic health education.
No_intervention: Control Group (No intervention)
Participants will receive only basic health education without taking Shenling Baizhu granules.
Sponsors
Collaborators: Affiliated Hospital of Nanjing University of Chinese Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Institute of Science, Beijing Tongrentang Co., Ltd., Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shuguang Hospital of Shanghai University of Traditional Chinese Medicine, Beijing Friendship Hospital, Sixth Affiliated Hospital, Sun Yat-sen University
Leads: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov