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NCT Number: NCT07525401

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

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.

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Key information

Conditions

Hepatitis A Digestive System Diseases Enterovirus Infections Hepatitis Hepatitis E Hepatitis E Virus Infection Hepatitis, Viral, Human Infections Liver Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ursodeoxycholic acid

Drug

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

Supportive Care

Other

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Combined Military Hospital, Pakistan

Other

Registry information

Acronym: AVH

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Apr 13, 2026
Registry last updated: Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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