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NOT YET RECRUITING
NCT07505056
PHASE3

Jianpi Lishi Jiedu Granules for Prevention of Postoperative Recurrence in Colorectal Advanced Adenomas

Sponsor: Nanjing First Hospital, Nanjing Medical University

View on ClinicalTrials.gov

Summary

This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of Jianpi Lishi Jiedu Granules in preventing postoperative recurrence of colorectal advanced adenoma. A total of 376 patients aged 18-80 years with endoscopically resected advanced adenoma and diagnosed with Spleen Deficiency and Dampness Toxin syndrome will be enrolled and randomly assigned to receive either Jianpi Lishi Jiedu Granules or placebo for 3 months. The primary endpoint is the adenoma recurrence rate at 1 year post-treatment, assessed by colonoscopy and pathological examination. Secondary endpoints include malignant transformation rate, TCM syndrome improvement, quality of life, gastrointestinal symptoms, and exploratory analyses of gut microbiota and inflammatory cytokines.

Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Study on the Intervention of Jianpi Lishi Jiedu Granules for Postoperative Recurrence of Colorectal Advanced Adenomas

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

376

Start Date

2026-05-01

Completion Date

2028-02-29

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

DRUG

Jianpi Lishi Jiedu Granules

The intervention is orally administered as one sachet of Jianpi Lishi Jiedu Granules, twice daily (1 hour after breakfast and dinner), for a treatment course of 3 months. All participants will begin medication after resuming oral intake following surgery for colorectal advanced adenoma (≥2 weeks post-procedure).

DRUG

Placebo granules

Participants in the control group will receive placebo granules orally (with the same specifications, appearance, dosage, and administration as the experimental group) for a treatment course of 3 months. All participants will begin medication after resuming oral feeding following surgery for colorectal advanced adenoma (≥2 weeks post-procedure).