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NCT07505056

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

Not yet recruiting Phase 3 Last updated 1 April 2026
What this trial tests

Phase 3 trial testing Jianpi Lishi Jiedu Granules in Colorectal Adenoma in 376 participants. Not yet recruiting.

Timeline
1 May 2026
Primary endpoint
31 December 2026
29 February 2028

Quick facts

Lead sponsorNanjing First Hospital, Nanjing Medical University
PhasePhase 3
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment376
Start date1 May 2026
Primary completion31 December 2026
Estimated completion29 February 2028

Drugs / interventions tested

Conditions studied

Sponsor

Nanjing First Hospital, Nanjing Medical University

Who can join

Adults 18 to 80, any sex, with Colorectal Adenoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Colorectal Adenoma

Currently open trials in the same condition.

Other Nanjing First Hospital, Nanjing Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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