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

Last updated: December 15, 2024
Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting

Phase

1

Condition

Hyponatremia

Bowel Dysfunction

Lactose Intolerance

Treatment

Tong-Xie-Yao-Fang

Clinical Study ID

NCT06737666
2022XLA162-3
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 orprobiotics such as yogurt in the past week.

  • Patients sign informed consent forms and are willing to receive appropriatetreatment, and volunteers are willing to cooperate in taking blood, urine, stool andother samples.

Exclusion

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), organicdiseases such as tumors indicated by recent colonoscopy, or systemic diseasesaffecting digestive motility (such as hyperthyroidism, diabetes);

  • Need to continue to use drugs that may affect gastrointestinal function (antidiarrheals, antidepressants, anti-anxiety drugs, intestinal flora regulationdrugs, 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 lactatingwomen;

  • Severe negative life events occurred during treatment;

  • There is currently any form of psychotherapy in progress;

  • No intention to cooperate.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Tong-Xie-Yao-Fang
Phase: 1
Study Start date:
May 29, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    Beijing, Beijing 100091
    China

    Active - Recruiting

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