IBS-D
Conditions
Interventions
Traditional Chinese Medicine Group:traditional Chinese medicine oral
Sponsors
Dongfang Hospital,Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. IBS-D patients with spleen deficiency and liver hyperactivity syndrome who meet the above diagnosis; 2. During the induction period (i.e. 14 ± 2 days before the start of the treatment phase), the weekly average abdominal pain score is>=3 points (11 point pain numerical scale, NRS-11); And at least once a week, the number of days when the Bristol fecal traits are classified as type 6 or type 7 is greater than or equal to 2 days; 3. IBS-SSS integral>=175; 4. People aged between 18 and 65 5. Agree to undergo colonoscopy and no abnormalities were found during colonoscopy; 6. The patient signs an informed consent form and is willing to receive corresponding treatment.
Exclusion criteria
Exclusion criteria: 1. Diarrhea caused by colorectal tumors, malabsorption syndrome, lactose intolerance (combined with medical history), and systemic diseases in individuals confirmed to be infected with infectious diarrhea, inflammatory bowel disease, parasitic infection, and positive fecal occult blood. 2. People with diabetes, hyperthyroidism, or serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, or serious diseases that affect their survival (such as tumors). Abnormal liver and kidney function (AST, TBIL>1.5 times the upper limit of normal reference value, Scr exceeding the upper limit of normal value range), as well as clinically significant ECG abnormalities. 3. Patients with non IBS-D and other organic diseases of the digestive system, or those with abdominal pain or discomfort caused by other organic diseases. 4. Have a previous history of large stomach, liver, pancreas or intestine surgery (appendectomy, hemorrhoidectomy or polypectomy are allowed for more than 3 months), and have a previous history of cholecystectomy; 5. Those who are currently or need to continue using drugs that may affect gastrointestinal function (anticholinergic drugs, 5-HT3 receptor antagonists, antidiarrheals, prokinetic agents, antidepressants, anxiolytics, gut microbiota regulators, etc.); 6. Pregnant or lactating women, and those with recent pregnancy plans; 7. Patients with a history of allergies and severe food allergies to the relevant drugs used in the trial; 8. Those who suspect or have a history of alcohol or drug abuse; 9. Those who have participated in other clinical trials within three months; 10. Those with contraindications for colonoscopy examination. 11. Researchers believe that there are patients with unsuitable factors for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IBS-SSS scale;Fecal response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Single symptom analysis and evaluation;TCM syndrome efficiency evaluation;quality of life evaluation; | — |
Countries
China
Contacts
Public ContactXie Chune
Dongfang Hospital Beijing University of Chinese Medicine
Outcome results
None listed