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

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.

NCT Number	NCT07505056
Lead Sponsor	Nanjing First Hospital, Nanjing Medical University Collaborators: Jiangsu Province Hospital of Traditional Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Changzhou Hospital of Traditional Chinese Medicine, Kunshan Hospital of Traditional Chinese Medicine
Conditions	Colorectal Adenoma
Enrollment	376 participants
Start Date	2026-05-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2028-02-29 (estimated)
Updated on ClinicalTrials.gov	2026-04-01