RecruitingPhase 1NCT06737666

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


Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Enrollment

60 participants

Start Date

May 29, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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.

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Interventions

DRUGTong-Xie-Yao-Fang

Tong-Xie-Yao-Fang granules were taken 2 bags at a time, 2 times per day at 1h after meal for 4 weeks.


Locations(1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

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NCT06737666


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