Xiyuan Hospital of China Academy of Chinese Medical Sciences
Phase
Phase 1
Started
2023-05-29
Last updated
2024-12-17
Condition(s) studied
Diarrhea-predominant Irritable Bowel Syndrome
Investigational drug(s) / intervention(s)
Tong-Xie-Yao-Fang
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.
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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Fecal metagenomic detection of bacteria associated with Trp metabolism — 16weeks
Serum detection by Elisa — 16weeks
Serum Trp metabolism was measured by metabolomics — 16weeks
Th17/Treg ratio in peripheral blood was measured by flow cytometry — 16weeks
Colon tissue was detected by immunofluorescence and histochemistry analysis — 16weeks Foxp3 ,RORrt ,AhR ,IDO1 ,Tyn
Trial sites (1)
Facility
City
Region
Status
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing
Beijing Municipality
Recruiting
More Xiyuan Hospital of China Academy of Chinese Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.