Recruiting

Tong-Xie-Yao-Fang for Diarrhea-predominant Irritable Bowel Syndrome

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What is being tested

Tong-Xie-Yao-Fang

Drug
Who is being recruted

From 18 to 70 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2023
See protocol details

Summary

Principal SponsorXiyuan Hospital of China Academy of Chinese Medical Sciences
Study ContactFengyun Wang, professor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 29, 2023

Actual date on which the first participant was enrolled.

This study focuses on a condition called diarrhea-predominant irritable bowel syndrome (IBS-D), which is a type of digestive system disorder causing frequent diarrhea and stomach pain. The exact cause of IBS-D is not well understood, and there are no specific treatments available. Traditional Chinese Medicine offers a treatment approach by using a formula called Tong-Xie-Yao-Fang (TXYF), which aims to balance the body's liver and spleen functions. Previous research indicates that TXYF can significantly alleviate IBS-D symptoms, such as reducing diarrhea and abdominal pain, thereby improving patients' quality of life. This study aims to explore how TXYF affects the body's immune system and intestinal environment, which may play a role in IBS-D. Participants in this study will receive the Tong-Xie-Yao-Fang treatment. Researchers will study the effects of this treatment on the participants' intestinal bacteria and overall metabolism. By analyzing these changes, the study aims to understand how TXYF helps in alleviating IBS-D symptoms. The trial is set up to evaluate the safety and effectiveness of this traditional medicine approach, providing more insights into potential new treatments for IBS-D. No specific risks or benefits are mentioned, but the study hopes to contribute valuable information about managing this challenging condition.

Official TitleEffects of Tong-Xie-Yao-Fang in Regulating Treg/Th17 Imbalance of Diarrhea-predominant Irritable Bowel Syndrome by Trp-Kyn-AhR Pathway
NCT06737666
Principal SponsorXiyuan Hospital of China Academy of Chinese Medical Sciences
Study ContactFengyun Wang, professor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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.
8 exclusion criteria prevent from participating
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;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, ChinaOpen Xiyuan Hospital of China Academy of Chinese Medical Sciences in Google Maps
Recruiting
One Study Center