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Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome

NCT07688161 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-07-07

No results posted yet for this study

Summary

This prospective, open-label, randomized controlled clinical trial aims to evaluate the clinical efficacy and safety of Jingfang Granules in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) with cold-dampness encumbering the spleen syndrome, and to explore its potential mechanisms of action. A total of 106 patients with IBS-D of cold-dampness encumbering the spleen syndrome are planned to be enrolled and randomly assigned to the experimental group and the control group, with 53 patients in each group. The treatment will last for 4 weeks, followed by a 12-week follow-up period. The primary outcome measure is the IBS Severity Scoring System (IBS-SSS). Secondary outcomes include the Traditional Chinese Medicine (TCM) syndrome score, the Bristol Stool Form Scale, patient-reported outcome (PRO) scales, the IBS Quality of Life (IBS-QOL) questionnaire, recurrence rate, and others. Exploratory measures, such as immune-inflammatory cytokines and biomarkers related to intestinal mucosal barrier function, will also be observed.

Conditions

  • Diarrhea-predominant Irritable Bowel Syndrome

Interventions

DRUG

Trimebutine Maleate Tablets

Oral administration of Trimebutine Maleate Tablets, 100 mg per tablet, one tablet each time, three times daily, for 4 weeks.

DRUG

Jingfang Granules

Oral administration of Jingfang Granules, 15 g per sachet, one sachet each time, three times daily, for 4 weeks.

Sponsors & Collaborators

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-01-31
Completion
2028-02-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07688161 on ClinicalTrials.gov