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

NCT07525401 | Not Yet Recruiting

• 2 other identifiers: pendingCMH Malir
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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 E Virus Infection; Hepatitis A

Keywords

Acute viral hepatitis; Ursodeoxycholic acid; UDCA; Hepatitis A; Hepatitis E

Outcome Measures

Primary Outcomes (1)

• Change in serum total bilirubin levels

  Mean reduction in serum total bilirubin from baseline to Day 7 in patients receiving ursodeoxycholic acid compared to control group

  7 days

Study Arms (2)

UDCA

EXPERIMENTAL

Patients receiving ursodeoxycholic acid in addition to standard care Intervention:

Drug: Ursodeoxycholic Acid

Control Group

ACTIVE COMPARATOR

Supportive management for acute viral hepatitis

Other: Supportive Care

Interventions

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.

Also known as: UDCA

UDCA

Supportive Care OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Combined Military Hospital, Pakistan: lead

MeSH Terms

Conditions

Hepatitis A; Hepatitis E

Interventions

Ursodeoxycholic Acid; Palliative Care

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate trainee

Model Details: A Quasi-experimental design There is an intervention group (receiving UDCA + standard care) and a control group (receiving standard care only) standard care is fluids, anti-emetic medicines like Domperidone

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03