Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07525401
NA

Comparative Evaluation of Oral Ursodeoxycholic Acid in Reducing Bilirubin Levels Among Patients With Acute Viral Hepatitis

Sponsor: Combined Military Hospital, Pakistan

View on ClinicalTrials.gov

Summary

Hepatitis is an inflammatory condition of the liver that has emerged as a significant global health concern due to its widespread prevalence. Data on ursodeoxycholic acid in acute viral hepatitis remain limited. Some studies suggest its positive effect in cholestatic phase of viral hepatitis. UDCA may reduce cholestatic symptoms like jaundice and pruritus potentially shortening hospital stay and improving patient outcomes. However, robust clinical data supporting its routine use in acute viral hepatitis are lacking, and current treatment remains largely supportive. Given the high burden of acute viral hepatitis in our region and the potential for UDCA to improve cholestatic phase of AVH there is a clear need for well-designed clinical studies evaluating its therapeutic role. This study aims to evaluate the role of oral ursodeoxycholic acid in biochemical recovery of patients with acute viral hepatitis. If positive role is confirmed, it will be incorporated in standard treatment and if no role is found unnecessary use will be discouraged. Null Hypothesis (H₀): Oral ursodeoxycholic acid has no significant effect on the bilirubin levels of patients with acute viral hepatitis. H₀: There is no statistically significant difference in bilirubin levels between patients receiving ursodeoxycholic acid and those receiving supportive care alone. Alternative Hypothesis (H₁): Oral ursodeoxycholic acid reduces bilirubin levels in patients with acute viral hepatitis. H₁: There is statistically significant difference in bilirubin levels between patients receiving ursodeoxycholic acid and those receiving supportive care alone.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2026-04

Completion Date

2026-10

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

DRUG

Ursodeoxycholic Acid

For UDCA Arm Ursodeoxycholic acid administered orally at a dose of 10 mg/kg/day in 2 divided doses for 7 days, in addition to standard supportive care, for patients with acute viral hepatitis fulfilling inclusion criteria \*standard supportive management including hydration and antiemetics. For Control Arm Patients receive standard supportive care for acute viral hepatitis without administration of ursodeoxycholic acid.

OTHER

Supportive Care

Standard supportive treatment including hydration, antiemetics, and monitoring without administration of ursodeoxycholic acid.