Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowe… (NCT07688161) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome
China106 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a Chinese herbal medicine called Jingfang Granules specifically for people diagnosed with a pattern called 'Cold-Dampness Disturbing Spleen Syndrome' — how would you determine whether my IBS-D fits that traditional Chinese medicine diagnosis, and am I even a candidate to discuss this study?
2Since this trial hasn't started recruiting yet, what are my options right now while I wait — should I consider standard treatments first, or would starting those affect my eligibility if I later want to participate?
3The trial measures success using something called the IBS Severity Scoring System — can you explain what kind of improvement in my daily symptoms that scale actually captures, and what would count as a meaningful change for someone in my situation?
4Because this is a Phase 3 trial, there should be some earlier safety data on Jingfang Granules — what do you know about any side effects or risks that showed up in prior studies, and are there any interactions I should be aware of given my current medications or health conditions?
5If I were to discuss enrolling in this trial once it opens, what would the practical demands look like — how many visits, how long would I be taking the granules, and is there a placebo group I might be assigned to instead of the active treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Irritable Bowel Syndrome Severity Scoring System scale
Timeframe: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
Trial details
NCT IDNCT07688161
SponsorNanjing First Hospital, Nanjing Medical University
. 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;