Clinical trial NCT06930157: Multi-Center Clinical Trial of Shenling Baizhu Granules for Preventing Low-Risk Colorectal Adenoma Recurrence
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Low-risk Colorectal Adenoma
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Adenoma Recurrence Rate
timeFrame: At 3 years after enrollment
Secondary outcomes:
measure: Rate of Advanced Adenoma or Cancer Development
timeFrame: At 3 years after enrollment
measure: TCM Syndrome Survey
timeFrame: At baseline, 6 months, 12 months, 18 months， 24 months and 36 months
Other outcomes:
Locations:
Study officials:
References: