irritable bowel syndrome
Conditions
Interventions
Kurarinone:Abbott Products SAS + Kurarinone
control group:Abbott Products SAS
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age 18-60, male and female; Patients who were diagnosed with IBS based on Rome IV diagnostic criteria, that is, their clinical manifestations were mainly abdominal pain; Have had an average of at least 1 day of symptoms per week in the past 3 months, with a course of disease of at least 6 months; At the same time accompanied by the following two or more related conditions: (1) related to defecation; (2) Changes in stool frequency are related; (3) changes related to the shape (appearance) of stool; The patients were able to complete the questionnaire of the patient quality of Life scale before and after treatment using the questionnaire star. Patients agreed not to make any new major lifestyle changes that might affect IBS symptoms (for example, starting a new diet, or changing their usual exercise patterns) from the time of enrollment until the end of the last trial visit; Voluntary informed consent.
Exclusion criteria
Exclusion criteria: There are organic gastrointestinal diseases that need to be ruled out. Patients with chronic non-atrophic gastritis could be enrolled; Patients with chronic atrophic gastritis reported by upper gastrointestinal endoscopy could be included in the study group if the results were not clinically significant according to the clinical judgment of the researchers. Have chronic liver disease, chronic pancreatitis, tuberculous peritonitis and other digestive system parenteral diseases (except chronic cholecystitis and gallstone patients without typical biliary colic); History of abdominal and pelvic surgery, such as cholecystectomy (after caesarean section, appendectomy for patients with no intestinal complications, and after treatment of intestinal polyps); Other systemic diseases, including serious diseases of the heart, lung, kidney and other important organs, immune regulatory diseases, metabolic diseases (diabetes, thyroid disease) or malignant tumors, reproductive system diseases such as ovarian cyst, endometriosis, etc.; Abnormalities in routine stool results of clinical significance; Significant abnormalities in laboratory tests or electrocardiograms that, as determined by the investigator, may compromise the patient's safety or successful completion of the clinical study include: hemoglobin =133umol/L, female serum creatinine >=124umol/L; Or creatinine clearance 1.5*ULN and/or ALT>1.5*ULN and/or total bilirubin >1.5*ULN; Patients with severe mental illness or HAMD score >20; Unexplained anemia, emaciation, fever, etc.; A history of drug or alcohol abuse; People who are allergic to the drug in this study; Pregnant or lactating women; Less than 3 months after participating in or completing other clinical trials; Other researchers did not consider it suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical signs and symptoms;Adverse reaction; | — |
Countries
China
Contacts
Public ContactCaiping Gao
Sichuan Provincial People's Hospital
Outcome results
None listed