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

NCT07688161 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: KY20260402-10
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Biomarker

  before treatment, after 4 weeks of treatment

• Evaluation of the efficacy of Chinese medicine evidence

  before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment

• Patient-Reported Outcome scale

  before treatment, after 4 weeks of treatment

• Irritable Bowel Syndrome Quality of Life scale

  before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

  Baseline (before treatment) to Week 4

Study Arms (2)

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.

Drug: Trimebutine Maleate Tablets

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.

Drug: Jingfang Granules

Interventions

Trimebutine Maleate Tablets DRUG

Oral administration of Trimebutine Maleate Tablets, 100 mg per tablet, one tablet each time, three times daily, for 4 weeks.

Also known as: Trimebutine Tablets

Treatment with Trimebutine Maleate Tablets

Jingfang Granules DRUG

Oral administration of Jingfang Granules, 15 g per sachet, one sachet each time, three times daily, for 4 weeks.

Treatment with Jingfang Granules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospitai

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Interventions

Trimebutine

Intervention Hierarchy (Ancestors)

Hydroxybenzoate Ethers; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Central Study Contacts

Wanli Liu, Doctorate

CONTACT

86 18502506688; njzxjh001@njucm.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)