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Impact of Ursodeoxycholic Acid on Clinical Outcomes in Patients with Acute Pancreatitis: A Randomized Controlled Trial

Impact of Ursodeoxycholic Acid on Clinical Outcomes in Patients with Acute Pancreatitis: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120559
Enrollment
Unknown
Registered
2026-03-17
Start date
2026-03-18
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pancreatitis

Interventions

Control group:Conventional therapy (fasting, gastrointestinal decompression, fluid resuscitation, inhibition of gastric and pancreatic secretion, suppression of pan
Ursodeoxycholic acid (Ursofalk) group:Ursodeoxycholic acid (Ursofalk)

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 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

MeasureTime frame
Incidence of new-onset SIRS within 7 days or duration of persistent SIRS.;

Secondary

MeasureTime frame
Intestinal function recovery;Laboratory parameters;Infection-related indicators;

Countries

China

Contacts

Public ContactXiong Huifang

The first affiliated hostipal of nanchang university

1043571730@qq.com+86 18970056474

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026