irritable bowel syndrome
Conditions
Interventions
Group 1:duloxetine
Group 2:duloxetine + pivonium bromide
Sponsors
Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital Digestive Department
Eligibility
Sex/Gender
All
Age
24 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria in order to be included in the study: 1. The subject volunteered to participate in the study and signed an informed consent form; 2. Aged 24-65 years old, male or female; 3. Patients diagnosed with irritable bowel syndrome (IBS) based on the Rome IV diagnostic criteria, ie recurrent abdominal pain, with an average episode of at least 1 day per week for the last 3 months, with at least 2 of the following characteristics: 1 abdominal pain associated with defecation; 2 accompanied by changes in the frequency of defecation; 3 accompanied by changes in fecal traits (appearance). Pre-diagnostic symptoms appear for at least 6 months, and meet the above diagnostic criteria for the past 3 months; and can be divided into IBS-D (diarrhea-based diarrhea-type IBS) according to the Bristol stool trait scale, IBS-C Constipation type IBS), IBS-M (mixed IBS alternating between loose feces and dry hard feces at different times); 4. The BPI score (24-hour average score) of the abdominal pain intensity at least 2 days during the screening period (ie, within 7 days before the start of the treatment phase) >=4 points; 5. The patient is willing to discontinue any medication for the violation of the symptoms of abdominal pain used in the pre-treatment phase and switch to the medication prescribed by the protocol; 6. The patient agrees that during the entire study period after the study, the lifestyle does not make any new major changes that may affect the symptoms of IBS (eg, starting a new diet or changing the usual pattern of exercise); 7. The hospital or the top three teaching hospitals have a recurrence of the disease after a colonoscopy report within one year, including patients with colon polyps (less than 3 mm, less than 5) who have recurred symptoms within one year after endoscopic treatment; or screening The colonoscopy of the former hospital or the top three teaching hospital is normal, but the history of bowel preparation needs to be selected in the next episode.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following conditions will not be included in the study: 1. Those who are allergic to the study drug duloxetine; 2. Those with previous history of increased intraocular pressure or narrow angle glaucoma; 3. There are organic diseases of the gastrointestinal tract, such as: chronic pancreatitis, inflammatory bowel disease, intestinal tuberculosis, malabsorption syndrome, celiac disease, gastrointestinal tumors or other organic diseases; 4. Previous history of abdominal and pelvic surgery, such as cholecystectomy, etc. (except for appendectomy and intestinal polyps within 1 year after treatment and polyps =133umol/L, female serum creatinine >=124umol / L; or creatinine clearance 1.5xULN and / or ALT > 1.5xULN and / or total bilirubin > 1.5xULN; 8. Patients with moderate to severe depressive symptoms (preferably PHQ-9 score > 9 points, or optional HAMD >=17 points); 9. Patients with moderate to severe anxiety symptoms (the preferred GAD-7 score > 5 points, or optional HAMA > 14 points); 10. Those with a history of drug abuse or alcohol abuse; 11. Pregnant or lactating women; 12. Less than 3 months after attending or completing other clinical trials; 13. Other researchers believe that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| abdominal pain symptoms improvement; | — |
Countries
China
Contacts
Public ContactYing-hui Zhang
Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital Digestive Department
Outcome results
None listed