Diarrhea-predominant Irritable Bowel SyndromePhase 3NCT07688161
Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome
A Phase 3 study testing Trimebutine Maleate Tablets and Jingfang Granules in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diarrhea-predominant Irritable Bowel Syndrome
- What is being tested?
- Trimebutine Maleate Tablets and Jingfang Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing First Hospitai
Nanjing, Jiangsu, 210006
Wanli Liu, Doctorate, 86 18502506688, njzxjh001@njucm.edu.cn
About this study
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.
- Being tested
- Trimebutine Maleate Tablets, Jingfang Granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimebutine Maleate TabletsDrug
Also called Trimebutine Tablets
Oral administration of Trimebutine Maleate Tablets, 100 mg per tablet, one tablet each time, three times daily, for 4 weeks.
Jingfang GranulesDrug
Oral administration of Jingfang Granules, 15 g per sachet, one sachet each time, three times daily, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Jingfang Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: before treatment, after 4 weeks of treatment
Irritable Bowel Syndrome Quality of Life scale
Assesses the quality of life of patients with IBS.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688161
- Sponsor's protocol ID
- KY20260402-10
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome
- ClinicalTrials.gov ID
- NCT07688161
- Acronym / sponsor ID
- KY20260402-10
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Trimebutine Maleate Tablets | Active comparator | Drug: Trimebutine Maleate TabletsControl 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 | Drug: Jingfang GranulesExperimental group: Oral administration of Jingfang Granules, 15 g per sachet, one sachet each time, three times daily, for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimebutine Maleate TabletsAlso: Trimebutine TabletsOral administration of Trimebutine Maleate Tablets, 100 mg per tablet, one tablet each time, three times daily, for 4 weeks. | Drug | Treatment with Trimebutine Maleate Tablets |
| Jingfang GranulesOral administration of Jingfang Granules, 15 g per sachet, one sachet each time, three times daily, for 4 weeks. | Drug | Treatment with Jingfang Granules |
Primary outcome
Irritable Bowel Syndrome Severity Scoring System scale
Time frame: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
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.
7 secondary outcomes
Biomarker
Time frame: before treatment, after 4 weeks of treatment
Evaluation of the efficacy of Chinese medicine evidence
Time frame: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
Patient-Reported Outcome scale
Time frame: before treatment, after 4 weeks of treatment
Irritable Bowel Syndrome Quality of Life scale
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)
Time frame: Baseline (before treatment) to Week 4
Number of Participants with Clinically Significant Abnormalities in Safety Assessments
Time frame: Baseline (before treatment) to Week 4
Bristol Stool Form scale
Time frame: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trimebutine Maleate Tablets and Jingfang Granules in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanli Liu, Doctorate (86 18502506688, njzxjh001@njucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome Severity Scoring System scale (time frame: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.