Diarrhea-predominant irritable bowel syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meeting both the Western medicine diagnostic criteria for IBS-D and the traditional Chinese medicine (TCM) diagnostic criteria for liver stagnation and spleen deficiency syndrome; (2) A baseline Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score >75; (3) Aged between 18 and 65 years (including 18 and 65 years) with no restriction on gender; (4) Willing to receive and able to comply with the treatment protocol and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) IBS subtypes other than IBS-D; patients with infectious diarrhea inflammatory bowel disease colorectal tumors or other organic gastrointestinal diseases will be excluded; (2) Patients with diabetes hyperthyroidism or uncontrolled hypertension; patients with severe primary diseases of major organs; those with abnormal liver or kidney function (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels greater than 1.5 times the upper limit of normal; creatinine [Cr] levels above the upper limit of normal); or clinically significant electrocardiogram (ECG) abnormalities; (3) Patients with neurological diseases a history of psychiatric disorders or poor compliance; (4) Individuals with allergic constitutions a history of severe drug allergies or severe food allergies; (5) Patients with a history of gastrointestinal surgery (excluding cesarean section and appendectomy); (6) Pregnant or lactating women or those planning to become pregnant in the near future; (7) Patients who have participated in other clinical trials within the past month; (8) Patients deemed unsuitable for inclusion by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visceral sensitivity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bile acid metabolism;Inflammatory factors and neurotrophic factors;Irritable Bowel Syndrome-Quality of Life Measure;Irritable Bowel Syndrome symptom severity scale;Defecation situation;Anxiety and Depression Assessment;Intestinal flora;Farnesoid X Receptor/Nerve growth factor/Transient receptor potential vanilloid subfamily 1 signaling pathway; | — |
Countries
China
Contacts
Hospital of Chengdu University of Traditional Chinese Medicine