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Not yet recruiting NCT07688161

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

Phase III Interventional Diarrhea-predominant Irritable Bowel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trimebutine Maleate Tablets, Jingfang Granules.
Who it may be relevant to
Registry conditions: Diarrhea-predominant Irritable Bowel Syndrome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Primary outcome measures

  • Irritable Bowel Syndrome Severity Scoring System scale [Time frame: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment]
Secondary outcome measures (7)
  • Biomarker [Time frame: before treatment, after 4 weeks of treatment]
  • Evaluation of the efficacy of Chinese medicine evidence [Time frame: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment]
  • Patient-Reported Outcome scale [Time frame: before treatment, after 4 weeks of treatment]
  • Irritable Bowel Syndrome Quality of Life scale [Time frame: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment]
  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Baseline (before treatment) to Week 4]
  • Number of Participants with Clinically Significant Abnormalities in Safety Assessments [Time frame: Baseline (before treatment) to Week 4]
  • Bristol Stool Form scale [Time frame: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment]

Eligibility criteria

Inclusion criteria

  • Meet the Western medicine diagnostic criteria for diarrhea-predominant irritable bowel syndrome (IBS-D) (IBS symptoms lasting for at least 6 months, and meeting the Rome IV criteria in the past 3 months) and the traditional Chinese medicine diagnostic criteria for cold-dampness disturbing spleen syndrome;
  • Aged between 18 and 65 years, with no gender restriction;
  • Baseline IBS-SSS score ≥ 75;
  • No use of any medication for irritable bowel syndrome for at least 1 week before entering treatment;
  • Subjects are informed and voluntarily sign the informed consent form.

Exclusion criteria

  • Patients with severe cardiovascular, respiratory, liver, kidney, or other major organ diseases, diabetes, tumors, hematopoietic system disorders, nervous system diseases, or psychiatric disorders;
  • Patients with other organic digestive system diseases (e.g., peptic ulcer) or systemic diseases affecting gastrointestinal motility (e.g., hyperthyroidism, diabetes mellitus);
  • Patients currently using or requiring continuous use of medications that may affect gastrointestinal function (e.g., antidiarrheals, antidepressants, anxiolytics, intestinal microbiota regulators, antibiotics, etc.);
  • Patients who have taken antibiotics, steroids or other hormones, herbal preparations (including oral and intravenous), microecological preparations, or probiotics (such as yogurt) within the past 1 week;
  • Patients who have previously undergone abdominal or anorectal surgery;
  • Pregnant or breastfeeding women;
  • Patients with a history of allergy to relevant drugs or severe food allergy;
  • Patients who have participated in or are currently participating in other interventional clinical research studies within the past 3 months;
  • Patients who refuse to enroll in the observation or have other unstable factors, such as failure to take medication as prescribed, or taking other medications that affect the evaluation of efficacy, leading to inability to determine treatment effects, or incomplete data.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanjing First Hospitai — Nanjing

Identifiers

NCT: NCT07688161 · KY20260402-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗