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.
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;
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;
Parallel
Trimebutine Maleate Tablets
DrugOral administration of Trimebutine Maleate Tablets, 100 mg per tablet, one tablet each time, three times daily, for 4 weeks.
Jingfang Granules
DrugOral administration of Jingfang Granules, 15 g per sachet, one sachet each time, three times daily, for 4 weeks.
Irritable Bowel Syndrome Severity Scoring System scale
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.
Biomarker
Measure the levels of biomarkers such as IL-1β, IFN-γ, IL-6, TNF-α, diamine oxidase, D-lactic acid, and endotoxin to explore the mechanism of action.
Evaluation of the efficacy of Chinese medicine evidence
A quantitative scale formulated based on the Guiding Principles for Clinical Research of New Chinese Medicines and the diagnostic criteria for cold-dampness encumbering the spleen pattern, with graded scoring for primary and secondary symptoms. Lower scores indicate milder syndromes.
Patient-Reported Outcome scale
Assesses patients' self-perceived severity of core symptoms such as abdominal discomfort and bloating.
Irritable Bowel Syndrome Quality of Life scale
Assesses the quality of life of patients with IBS.
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