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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Trimebutine Maleate Tablets | Active Comparator | Control group: Oral administration of Trimebutine Maleate Tablets, 100 mg per tablet, one tablet each time, three times daily, for 4 weeks. |
|
| Treatment with Jingfang Granules | Experimental | Experimental group: Oral administration of Jingfang Granules, 15 g per sachet, one sachet each time, three times daily, for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimebutine Maleate Tablets | Drug | Oral administration of Trimebutine Maleate Tablets, 100 mg per tablet, one tablet each time, three times daily, for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before treatment, after 4 weeks of treatment |
| Evaluation of the efficacy of Chinese medicine evidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wanli Liu, Doctorate | Contact | 86 18502506688 | njzxjh001@njucm.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospitai | Nanjing | Jiangsu | 210006 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2026 |
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|
| Jingfang Granules | Drug | Oral administration of Jingfang Granules, 15 g per sachet, one sachet each time, three times daily, for 4 weeks. |
|
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. |
| before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment |
| Patient-Reported Outcome scale | Assesses patients' self-perceived severity of core symptoms such as abdominal discomfort and bloating. | before treatment, after 4 weeks of treatment |
| Irritable Bowel Syndrome Quality of Life scale | Assesses the quality of life of patients with IBS. | before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment |
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse events (TEAEs) will be assessed throughout the study period based on spontaneous subject reports, physical examinations, and investigator observations. Incidence, severity (graded according to CTCAE v5.0), and relationship to study treatment will be recorded. The unit of measure for this outcome is the count of participants experiencing at least one TEAE. | Baseline (before treatment) to Week 4 |
| Number of Participants with Clinically Significant Abnormalities in Safety Assessments | Safety assessments include vital signs (temperature, respiratory rate, heart rate, and blood pressure), clinical laboratory tests (hematology, blood biochemistry, urinalysis, and stool examination), and 12-lead electrocardiography (ECG). The number of participants with at least one clinically significant abnormal finding according to protocol-defined clinical significance criteria will be reported. The unit of measure for this outcome is the count of participants; participants with multiple abnormal findings will be counted only once for this measure. | Baseline (before treatment) to Week 4 |
| Bristol Stool Form scale | Assesses stool form, classified into types 1 to 7. The mean daily BSFS score recorded on diary cards during the treatment period, and the typical BSFS type at each visit time point will be recorded. | before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment |
| Jun 15, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2026 | Jun 15, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D014287 | Trimebutine |
| ID | Term |
|---|---|
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
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