Acute pancreatitis
Conditions
Interventions
Ursodeoxycholic acid (Ursofalk) group:In addition to conventional therapy, ursodeoxycholic acid 250 mg was taken orally three times daily after meals for 4 weeks
if the hospital stay was shorter than 4 weeks, treatment continued until the 4-week endpoint.
control group:Conventional therapy (fasting, gastrointestinal decompression, fluid resuscitation, inhibition of gastric and pancreatic secretion, suppression of pancreatic enzyme activity, improvement
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
15 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for acute pancreatitis; 2.Aged between 18 and 75 years; 3.Onset within 72 hours; 4.Modified Harmless Acute Pancreatitis Score >= 3 or SIRS >= 2; 5.Signed informed consent form
Exclusion criteria
Exclusion criteria: 1.SAP patients with organ failure at admission (Marshall score >=2); 2.Known hypersensitivity to ursodeoxycholic acid; 3.Imaging evidence (ultrasound, CT, etc.) of biliary obstruction, including common bile-duct stones or pancreaticobiliary tumours; 4.Severe hepatic dysfunction (ALT or AST > 3 × ULN, or total bilirubin > 2 × ULN); 5.Severe impairment of vital organs (heart, lung, kidney, etc.); 6.Pregnant or lactating women; 7.Participation in another clinical trial; 8.Any condition that, in the investigator’s opinion, would expose the subject to unacceptable risk of complications, interfere with the evaluation of the investigational product, or confound the interpretation of safety or efficacy data; 9.Failure to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of new-onset SIRS within 7 days or duration of persistent SIRS.; | — |
Secondary
| Measure | Time frame |
|---|---|
| infection-related indicators;intestinal function recovery;laboratory parameters; Complications and outcome related indicators; | — |
Countries
China
Contacts
Public ContactHuifang Xiong
The First Affiliated Hospital of Nanchang University
Outcome results
None listed