About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients of either gender
aged >18 years to 50 years with acute viral hepatitis are included
Disqualifiers
Patients having Hepatitis B, C
hepatocellular carcinoma
primary biliary cholangitis
choldocholithiasis
Trial design
Parallel
Treatments tested in this trial
Ursodeoxycholic Acid
DrugFor 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.
Supportive Care
Other interventionStandard supportive treatment including hydration, antiemetics, and monitoring without administration of ursodeoxycholic acid.
Treatment groups
Trial outcomes
Primary outcomes
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
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: