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

S

Shanghai Jiao Tong University School of Medicine

Status and phase

Begins enrollment this month
Phase 4

Conditions

Low-risk Colorectal Adenoma

Treatments

Drug: Shenling Baizhu granules (TCM patent medicine)

Study type

Interventional

Funder types

Other

Identifiers

NCT06930157
KY2024-191-C

Details and patient eligibility

About

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.

Enrollment

624 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

624 participants in 2 patient groups

Experimental Group (Shenling Baizhu Granules)
Experimental group
Description:
Participants will take Shenling Baizhu granules (6 grams, 3 times daily) for 6 months each year for 2 years, along with basic health education.
Treatment:
Drug: Shenling Baizhu granules (TCM patent medicine)
Control Group (No intervention)
No Intervention group
Description:
Participants will receive only basic health education without taking Shenling Baizhu granules.

Trial contacts and locations

0

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Central trial contact

Xiaobo Li

Data sourced from clinicaltrials.gov

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