Multi-Center Clinical Trial of Shenling Baizhu Granules for Preventing Low-Risk Colorectal Adenoma Recurrence

Launched by SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether a herbal medicine called Shenling Baizhu granules can help prevent the return of low-risk colorectal adenomas, which are small growths in the colon that can sometimes lead to cancer if they come back. The study will involve 624 adults aged 18 to 70 who have recently had low-risk adenomas removed. Researchers want to find out if taking these granules can lower the chances of adenomas returning, how safe they are for long-term use, and which patients might benefit the most from this treatment.

If you choose to participate, you will either take Shenling Baizhu granules three times a day or receive no treatment for six months each year over two years. You will have regular check-ups, including giving samples like blood and stool, and you’ll fill out health questionnaires. After three years, a colonoscopy will be done to see if any adenomas have come back. To be eligible, you must have had a recent diagnosis of low-risk colorectal adenoma and be willing to provide consent to participate. However, certain health conditions and treatments may exclude you from joining. This study is not yet recruiting, but it will last a total of four years.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed with low-risk colorectal adenoma
• • Complete colonoscopy examination (adequate bowel preparation, cecal intubation, withdrawal time \>6 minutes), with endoscopic resection performed including snare polypectomy, EMR, EPMR, ESD
• • Within 1 month after adenoma resection
• • Age 18-70 years
• • Willing to provide written informed consent
• Exclusion Criteria:
• • Incomplete adenoma resection
• • Long-term use of aspirin, folic acid, calcium, or vitamin D supplements
• • Familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch syndrome), or other hereditary polyposis syndromes
• • Severe inflammatory bowel disease
• • History of malignancy within past 5 years (excluding basal cell carcinoma of the skin and/or cervical intraepithelial neoplasia after surgery)
• • Pregnant or lactating women
• • Severe cardiovascular disease, cerebrovascular disease, liver or kidney dysfunction, or diabetes
• • Severe mental illness that prevents compliance with colonoscopy examination