NCT06737666

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diarrhea-predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Tong-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.

Timeline

• Start date: 2023-05-29
• Primary completion: 2025-10-08
• Completion: 2025-12-01
• First posted: 2024-12-17
• Last updated: 2024-12-17

Locations

1 site across 1 country: China