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

NCT07525401 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Hepatitis A
  • Hepatitis E Virus Infection

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.

Sponsors & Collaborators

  • Combined Military Hospital, Pakistan

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-10-31
Completion
2026-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07525401 on ClinicalTrials.gov