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Tests treatment safety and results for Diarrhea-predominant Irritable Bowel Syndrome
Official title Study on the Effectiveness and Mechanism of Tong-Xie-Yao-Fang in Treating Diarrhea-predominant Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT06737666
What this study is testing
What is Tong-Xie-Yao-Fang?
Tong-Xie-Yao-Fang is an investigational medicine, being studied as a potential treatment for diarrhea-predominant irritable bowel syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Patients sign informed consent forms and are willing to receive appropriate treatment, and volunteers are willing to cooperate in taking blood...
You likely can't join if
- 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...
- Need to continue to use drugs that may affect gastrointestinal function (antidiarrheals, antidepressants, anti-anxiety drugs, intestinal flora...
- 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;
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.