Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome
Condition(s) studied
Investigational drug(s) / intervention(s)
Trimebutine Maleate Tablets: Oral administration of Trimebutine Maleate Tablets, 100 mg per tablet, one tablet each time, three times daily, for 4 weeks.
Jingfang Granules: Oral administration of Jingfang Granules, 15 g per sachet, one sachet each time, three times daily, for 4 weeks.
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.
Eligibility
Primary outcome measure(s)
- Irritable Bowel Syndrome Severity Scoring System scale — before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
This scale is an internationally recognized assessment tool for IBS symptom severity, with a total score ranging from 0 to 500. Lower scores indicate milder symptoms.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Nanjing First Hospitai | Nanjing | Jiangsu |
More Nanjing First Hospital, Nanjing Medical University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07688161 on ClinicalTrials.gov ↗ ← All trials in China