Actively Recruiting
Multi-center Randomized Controlled Clinical Study of Shenling Baishu Granule to Prevent the Recurrence of Low-risk Colorectal Adenoma
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-01-28
624
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiao Tong University School of Medicine
Lead Sponsor
A
Affiliated Hospital of Nanjing University of Chinese Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Multi-center Randomized Controlled Clinical Study of Shenling Baishu Granule to Prevent the Recurrence of Low-risk Colorectal Adenoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets the diagnostic criteria for low-risk colorectal adenoma.
- Has undergone a high-quality colonoscopy with adequate bowel preparation, cecal intubation, and at least 6 minutes withdrawal time.
- Received endoscopic minimally invasive polypectomy.
- Within 3 months after adenoma resection.
- Aged 18 to 70 years, any sex.
- Willing to participate and provide written informed consent.
You will not qualify if you...
- Incomplete adenoma resection.
- Long-term use of aspirin, folic acid, calcium supplements, vitamin D, or similar agents.
- Known hereditary polyposis syndromes or hereditary colorectal cancer syndromes.
- Colonoscopy findings suggesting inflammatory bowel disease.
- History of cancer in the past 5 years.
- Pregnant, breastfeeding, or planning pregnancy.
- Severe cardiovascular, cerebrovascular, liver, kidney diseases, or diabetes.
- Severe psychiatric disorders preventing cooperation.
- Conditions preventing oral intake of the study drug.
- Participation in another clinical study within the past 3 months or currently.
- Any other condition deemed unsuitable by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Renji Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
X
Xiaobo Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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