Ancient herbal formula jingfang granules put to the test against IBS diarrhea
NCT ID NCT07688161
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This clinical trial investigates whether Jingfang Granules, a traditional Chinese herbal medicine, can safely and effectively reduce symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D) in people with a specific pattern called cold-dampness disturbing spleen syndrome. The study compares Jingfang Granules to the standard drug trimebutine over 4 weeks of treatment, followed by 12 weeks of follow-up. Researchers will measure changes in IBS severity, stool consistency, quality of life, and explore how the treatment might work by looking at immune and gut barrier markers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Jingfang Granules (Chinese herbal formula)
- What this could lead to
- If effective, Jingfang Granules could offer a new, well-tolerated treatment option for people with diarrhea-predominant IBS who have cold-dampness spleen syndrome.
- What could go wrong
- This is a Phase 3 trial with 106 participants, so results may not apply to all IBS patients. Herbal remedies can vary in quality and may cause side effects or interact with other medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 106 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nanjing First Hospitai
Nanjing, Jiangsu, 210006, China
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