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NCT06930157 | NOT YET RECRUITING | Low-risk Colorectal Adenoma

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

Shanghai Jiao Tong University School of Medicine

Information provided by (Responsible Party):

ξOBoL i

Brief Summary:

The goal of this clinical trial is to learn if Shenling Baizhu granules can prevent colorectal adenoma from coming back in people who had low-risk colorectal adenomas removed. The main questions it aims to answer are: * Can Shenling Baizhu granules lower the rate of colorectal adenoma returning after removal? * How safe is Shenling Baizhu granules when used long-term for preventing adenoma? * Which patients are most likely to benefit from this treatment? Researchers will compare Shenling Baizhu granules to no treatment to see if the medicine works to prevent adenomas from returning. Participants will: * Take Shenling Baizhu granules (6 grams, 3 times daily) or receive no treatment for 6 months each year for 2 years * Have regular check-ups and provide blood, stool, saliva, and tissue samples * Get a colonoscopy after 3 years to check if any adenomas have returned * Fill out questionnaires about their symptoms and overall health throughout the study This study will include 624 adults aged 18-70 who recently had low-risk colorectal adenomas removed at participating hospitals. The total study duration is 4 years.

Condition or disease

Low-risk Colorectal Adenoma

Intervention/treatment

Shenling Baizhu granules (TCM patent medicine)

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 624 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : A Multi-Center, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of Shenling Baizhu Granules in Preventing Recurrence of Low-Risk Colorectal Adenoma
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2028-12-31
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Multi-Center Clinical Trial of Shenling Baizhu Granules for Preventing Low-Risk Colorectal Adenoma Recurrence

Location Details

NCT06930157

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