Ancient herbal formula jingfang granules put to the test against IBS diarrhea

NCT ID NCT07688161

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 106 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Nanjing First Hospitai

    Nanjing, Jiangsu, 210006, China

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