Effect of Tong-Xie-Yao-Fang on diarrhea-predominant IBS
Effects of Tong-Xie-Yao-Fang in Regulating Treg/Th17 Imbalance of Diarrhea-predominant Irritable Bowel Syndrome by Trp-Kyn-AhR Pathway
This study is testing if a traditional Chinese medicine called Tong-Xie-Yao-Fang can help people with diarrhea-predominant irritable bowel syndrome feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Xiyuan Hospital of China Academy of Chinese Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06737666 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Tong-Xie-Yao-Fang (TXYF), a traditional Chinese medicine formula, in treating diarrhea-predominant irritable bowel syndrome (IBS-D). It aims to clarify the mechanism of TXYF by studying the intestinal flora and host co-metabolism using metabolomics and metagenomics. The research focuses on the pathogenesis of liver depression and spleen deficiency, which are believed to contribute to IBS-D symptoms. Participants will include IBS-D patients and healthy volunteers who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 diagnosed with diarrhea-predominant IBS-D who have not taken certain medications recently.
Not a fit: Patients with serious organ diseases or other significant gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from diarrhea-predominant IBS-D.
How similar studies have performed: Previous studies have shown promising results for TXYF in improving IBS-D symptoms, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Xiyuan Hospital of China Academy of Chinese Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Fengyun Wang, professor
- Email: wfy811@163.com
- Phone: +86 (010)-62835610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.