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Study on the Effectiveness and Mechanism of Tong-Xie-Yao-Fang in Treating Diarrhea-predominant Irritable Bowel Syndrome | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Study on the Effectiveness and Mechanism of Tong-Xie-Yao-Fang in Treating Diarrhea-predominant Irritable Bowel Syndrome

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

NCT06737666•Xiyuan Hospital of China Academy of Chinese Medical Sciences

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Summary

Traditional Chinese Medicine focuses on the main pathogenesis of liver depression and spleen deficiency, and treats them from the perspective of soothing the liver and strengthening the spleen to treat on Diarrhea-predominant irritable bowel syndrome (IBS-D) . The classic formula for treating is the Tong-Xie-Yao-Fang (TXYF). Based on metabolomics and metagenomics, the research group studied the intestinal flora and host co metabolism of TXYF in the treatment of diarrhea predominant IBS-D, in order to clarify the mechanism of TXYF in the treatment of IBS-D.

Detailed Description

Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common clinical functional gastrointestinal disease with unclear mechanism, which is mostly induced by emotion. There is no specific treatment for this disease. Traditional Chinese Medicine focuses on the main pathogenesis of liver depression and spleen deficiency, and treats them from the perspective of soothing the liver and strengthening the spleen. The classic formula for treating is the Tong-Xie-Yao-Fang (TXYF).Previous studies of our research group have shown that TXYF can significantly improve the symptoms of abdominal pain and diarrhea in patients with IBS-D, and improve the quality of life of patients. The effectiveness and safety of TXYF in the treatment of IBS-D have been evaluated, and its mechanism of action has also been explored.Modern studies have shown that changes in the local immune microenvironment can affect intestinal immunity and neuroregulation, mucosal barrier damage and abnormal co-metabolism of flora and host, which may be important reasons for the occurrence and development of IBS-D, but the detailed mechanism is unclear.Therefore, based on metabolomics and metagenomics, the research group studied the intestinal flora and host co metabolism of TXYF in the treatment of diarrhea predominant IBS-D, in order to clarify the mechanism of TXYF in the treatment of IBS-D.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Key Dates

Start Date

May 29, 2023

Primary Completion Date

October 8, 2025

Completion Date

December 1, 2025

Last Updated

December 17, 2024

Enrollment

ESTIMATED participants

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Interventions

Tong-Xie-Yao-Fang

DRUG

Contacts

Fengyun Wang, professor

CONTACT

+86 (010)-62835610 wfy811@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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