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

Phase 3Not Yet RecruitingNCT07688161

Nanjing First Hospital, Nanjing Medical University106 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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; 2. Aged between 18 and 65 years, with no gender restriction; 3. Baseline IBS-SSS score ≥ 75; 4. No use of any medication for irritable bowel syndrome for at least 1 week before entering treatment; 5. Subjects are informed and voluntarily sign the informed consent form. Exclusion Criteria: 1. Patients with severe cardiovascular, respiratory, liver, kidney, or other major organ diseases, diabetes, tumors, hematopoietic system disorders, nervous system diseases, or psychiatric disorders; 2. Patients with other organic digestive system diseases (e.g., peptic ulcer) or systemic diseases affecting gastrointestinal motility (e.g., hyperthyroidism, diabetes mellitus); 3. Patients currently using or requiring continuous use of medications that may affect gastrointestinal function (e.g., antidiarrheals, antidepressants, anxiolytics, intestinal microbiota regulators, antibiotics, etc.); 4. 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; 5. Patients who have previously undergone abdominal or anorectal surgery; 6. Pregnant or breastfeeding women; 7. Patients with a history of allergy to relevant drugs or severe food allergy; 8. Patients who have participated in or are currently participating in other interventional clinical research studies within the past 3 months; 9. 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.

Outcomes

Primary Outcomes

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.

Time frame: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment

Secondary Outcomes

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.

Time frame: before treatment, after 4 weeks of treatment

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.

Time frame: 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.

Time frame: before treatment, after 4 weeks of treatment

Irritable Bowel Syndrome Quality of Life scale

Assesses the quality of life of patients with IBS.

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)

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.

Time frame: 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.

Time frame: 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.

Time frame: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts