Actively Recruiting
Effects of Tong-Xie-Yao-Fang on Immune Balance in Diarrhea-predominant Irritable Bowel Syndrome via Trp-Kyn-AhR Pathway
Led by Xiyuan Hospital of China Academy of Chinese Medical Sciences · Updated on 2024-12-17
60
Participants Needed
1
Research Sites
7 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common digestive disorder often linked to emotional factors, with unclear causes and no specific treatment. Traditional Chinese Medicine (TCM) sees liver depression and spleen deficiency as key issues and uses the classic Tong-Xie-Yao-Fang (TXYF) formula to soothe the liver and strengthen the spleen. Researchers are studying the effects and mechanisms of TXYF on IBS-D by examining its impact on intestinal flora and host metabolism through metabolomics and metagenomics techniques. The study evaluates the use of Tong-Xie-Yao-Fang granules taken twice daily, one hour after meals, for four weeks in patients with IBS-D. It includes an experimental group receiving TXYF and a healthy volunteer group without intervention. The research aims to clarify how TXYF influences the balance of immune and metabolic pathways related to IBS-D, focusing on the Trp-Kyn-AhR pathway and intestinal flora changes. Participants will provide samples of blood, urine, stool, and colon tissue for various tests over 16 weeks. These tests include measuring bacteria associated with tryptophan metabolism, assessing serum markers, and analyzing immune cell ratios and colon tissue through advanced laboratory methods. The study will monitor these outcomes to better understand TXYF's role in regulating immune balance and metabolism in IBS-D, with a total participation duration of 16 weeks.
CONDITIONS
Brief Title
Study on the Effectiveness and Mechanism of Tong-Xie-Yao-Fang in Treating Diarrhea-predominant Irritable Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- IBS-D patients and healthy volunteers meeting diagnostic criteria
- Aged between 18 and 70 years
- Have not taken antibiotics, steroids, hormones, Chinese herbal medicines, microecological preparations, or probiotics in the past week
- Patients willing to sign informed consent and receive appropriate treatment
- Volunteers willing to cooperate in providing blood, urine, stool, and other samples
You will not qualify if you...
- Serious heart, liver, kidney, blood, nervous system, or mental diseases
- Other organic digestive diseases such as peptic ulcers or tumors
- Systemic diseases affecting digestive motility like hyperthyroidism or diabetes
- Need to continue drugs affecting gastrointestinal function
- History of drug or severe food allergy relevant to the study
- Under 18 or over 75 years old, pregnant or lactating women
- Severe negative life events during treatment
- Currently undergoing any form of psychotherapy
- Unwillingness to cooperate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants take Tong-Xie-Yao-Fang granules, 2 bags at a time, twice daily, 1 hour after meals.
Trial Site Locations
Total: 1 location
1
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China, 100091
Actively Recruiting
Research Team
F
Fengyun Wang, professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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