Diarrhea Irritable Bowel Syndrome
Conditions
Interventions
Experimental group:Routine treatment combined with Tongxiening Granule
Control group:Routine treatment
Sponsors
Anhui Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Selection criteria: at least one of the three manifestations: insomnia and dreaming, irritability and irritability, and gastrointestinal symptoms changing with mood fluctuation, which met the IBS-D Roman IV diagnostic criteria. IBS diagnostic criteria: recurrent abdominal pain, with an average attack of at least 1 day a week in the past three months, accompanied by the following two or more items: (1) Relative to defecation; (2) Changes in defecation frequency; (3) Fecal traits (changes in appearance); IBS diarrhea type: (1) More than 1/4 (25%) of the stools were Bristol type 6 or 7; (2) and feces less than 1/4 (25%) were Bristol type 1 or type 2 fecal traits. Bristol fecal trait typing: (1) Type 1: Dispersed dried ball dung, such as nuts, is difficult to discharge; (2) Type 2: Sausage-like, multi-lump; (3) Type 3: Sausage-like, with cracks on the surface; (4) Type 4: Sausage-like or serpentine, smooth and soft; (5) Type 5: Soft block with clear boundary; (6) Type 6: flaky, brittle, or pasty; (7) Type 7: Water sample, no fixed ingredient. 1. The age ranges from 18 to 65 years (including 18 to 65 years), regardless of gender; 2. Colonoscopy was performed in the third-class A hospital one year before this enrollment to exclude intestinal cancer, ulcer, inflammation or other intestinal organic diseases; 3. B-mode ultrasonography was performed to exclude hepatobiliary and pancreatic diseases within one year before admission; 4. Within one month before enrollment, ECG examinations were performed in the center (the QT interval was within the normal range).
Exclusion criteria
Exclusion criteria: 1. those with history of abdominal surgery; 2. Digestive system organic diseases (including polyps, inflammatory bowel diseases, tumors, celiac disease, lactose intolerance, etc.); 3. Use any spasmolytic analgesics, gastrointestinal motility drugs, acid inhibitors, microecological agents, antibiotics, antidepressants, etc. within 2 weeks before enrollment; 4. B-mode ultrasonography showed hepatobiliary and pancreatic diseases. 5. Patients with hypertension and unstable blood pressure control; 6. Patients with history of diabetes mellitus, thyroid disease, systemic sclerosis, systemic lupus erythematosus, etc. 7. Patients with severe mental disorders (GAD7 (> 14 points), PHQ9 (> 15 points); 8. Pregnant women, lactating women or planned pregnancies; 9. Anaphylaxis patients taking Tongxieling Granules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom severity score and IBS quality of life score;General Anxiety Disorder ScaleGeneral Anxiety Disorder Scale(GAD-7);Health Questionnaire Depression Symptom Group Scale (PHQ-9);Changes of Serum Psychological Related Neurotransmitters; | — |
Countries
China
Contacts
Public ContactYu Yue
Anhui Provincial Hospital
Outcome results
None listed