Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 70

Effect of Tong-Xie-Yao-Fang on diarrhea-predominant IBS

Official title: Effects of Tong-Xie-Yao-Fang in Regulating Treg/Th17 Imbalance of Diarrhea-predominant Irritable Bowel Syndrome by Trp-Kyn-AhR Pathway

Run by Xiyuan Hospital of China Academy of Chinese Medical Sciences · NCT06737666 · Data updated 2026-11-12

This study is testing if a traditional Chinese medicine called Tong-Xie-Yao-Fang can help people with diarrhea-predominant irritable bowel syndrome feel better.

More Diarrhea-predominant Irritable Bowel Syndrome trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment60 (estimated)
SponsorXiyuan Hospital of China Academy of Chinese Medical Sciences
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedMay 29, 2023
Main results expectedOctober 8, 2025
Study endsDecember 2025
Registry record updatedDecember 17, 2024
Trial IDNCT06737666 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 70 diagnosed with diarrhea-predominant IBS-D who have not taken certain medications recently.

Probably not a fit

Patients with serious organ diseases or other significant gastrointestinal conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of Tong-Xie-Yao-Fang (TXYF), a traditional Chinese medicine formula, in treating diarrhea-predominant irritable bowel syndrome (IBS-D). It aims to clarify the mechanism of TXYF by studying the intestinal flora and host co-metabolism using metabolomics and metagenomics. The research focuses on the pathogenesis of liver depression and spleen deficiency, which are believed to contribute to IBS-D symptoms. Participants will include IBS-D patients and healthy volunteers who meet specific eligibility criteria.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from diarrhea-predominant IBS-D.

How similar studies have gone: Previous studies have shown promising results for TXYF in improving IBS-D symptoms, indicating potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* IBS-D patients and healthy volunteers meeting diagnostic criteria;
* Aged between 18 and 70;
* Have not taken antibiotics, steroids and other hormones, Chinese herbal preparations (including oral and intravenous injections), microecological preparations or probiotics such as yogurt in the past week.
* Patients sign informed consent forms and are willing to receive appropriate treatment, and volunteers are willing to cooperate in taking blood, urine, stool and other samples.

Exclusion Criteria:

* Patients with serious heart, liver, kidney and other major organ diseases, hematopoietic system, nervous system or mental diseases;
* Other organic diseases of the digestive system (such as peptic ulcers), organic diseases such as tumors indicated by recent colonoscopy, or systemic diseases affecting digestive motility (such as hyperthyroidism, diabetes);
* Need to continue to use drugs that may affect gastrointestinal function (antidiarrheals, antidepressants, anti-anxiety drugs, intestinal flora regulation drugs, antibiotics, etc.);
* Have a history of drug allergy or severe food allergy for research purposes;
* Patients under 18 years of age or over 75 years of age and pregnant or lactating women;
* Severe negative life events occurred during treatment;
* There is currently any form of psychotherapy in progress;
* No intention to cooperate.

Where it's running

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.