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

April 10, 2026 updated by: Khuld e Neha, Combined Military Hospital, Pakistan

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study design: A Quasi-experimental design There is an intervention group (receiving UDCA + standard care) and a control group (receiving standard care only) Study Setting: Medicine department of Combined Military Hospital, Malir, Karachi Study Duration: 6 months Sampling Technique: Non probability consecutive sampling technique

Sample Size:

Open Epi version 3, was used to calculate the sample size with a two-sided 95% confidence interval and 80% power. This was based on an expected mean difference of 0.3 mg/dL in bilirubin levels between the treatment group (mean = 4.1 mg/dL, SD = 0.5) and the control group (mean = 3.8 mg/dL, SD = 0.5) (6), a minimum of 44 participants per group was calculated to detect this difference, assuming equal variances and group sizes. The total sample size is calculated to be 88 (total N = 88), with 44 participants in each group.

Since the total estimated number of eligible admissions during the study period was 200 and the required sample size was 88, a sampling interval (k) of approximately 2 was calculated (k = 200/88 ≈ 2). A random starting point was selected to avoid periodic bias, and thereafter every 2nd eligible patient was included until the desired sample size was achieved.

Inclusion Criteria All patients of either gender, aged >18 years to 50 years with acute viral hepatitis are included.

Exclusion Criteria Patients having Hepatitis B, C, hepatocellular carcinoma, primary biliary cholangitis, choldocholithiasis and patients having normal bilirubin levels with AVH were excluded.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients of either gender
  • aged >18 years to 50 years with acute viral hepatitis are included

Exclusion Criteria:

  • Patients having Hepatitis B, C
  • hepatocellular carcinoma
  • primary biliary cholangitis
  • choldocholithiasis
  • patients having normal bilirubin levels with AVH were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UDCA

Patients receiving ursodeoxycholic acid in addition to standard care

Intervention:
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 Names:
  • UDCA
Active Comparator: Control Group
Supportive management for acute viral hepatitis
Other: Supportive Care
Standard supportive treatment including hydration, antiemetics, and monitoring without administration of ursodeoxycholic acid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum total bilirubin levels
Time Frame: 7 days
Mean reduction in serum total bilirubin from baseline to Day 7 in patients receiving ursodeoxycholic acid compared to control group
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Combined Military Hospital, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pending (Clinical Research Information Service)
  • CMH Malir (Other Identifier: CMH Malir)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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