Clinical Trial: Randomized Placebo-controlled Trial Evaluating the Safety and Efficacy of Silymarin Treatment in Patients With Acute Viral Hepatitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multicentre, Double-blind, Randomized, Placebo-controlled, Phase II/III Study to Evaluate the Safety and Efficacy of 280 mg and 420 mg Silymarin TID (Legalon® Capsules) Administered for Four We

Brief Summary: The purpose of this study is to assess whether two higher doses (280mg or 420mg three times daily)of silymarin therapy are safe and tolerable, and shorten the illness in patients with acute viral hepatitis compared to placebo.

Detailed Summary:

Currently, acute viral hepatitis (AVH) management is based on diet and rest and silymarin remains among the most popular herbs being used for treating viral hepatitis both in the U.S. and abroad. Although numerous randomized clinical trials have been conducted to assess the efficacy of silymarin on chronic hepatitis C, very few studies were done to assess the efficacy of silymarin in acute viral hepatitis. Among those, efficacy of silymarin has not been established. This could be attributed to the small number of studies conducted, small sample sizes, high drop out rates, and low doses of silymarin used. Therefore, it is justified to evaluate silymarin safety and efficacy using higher doses than previously studied in AVH.

Primary safety objective:

• To assess safety and tolerability of two silymarin doses in patients with AVH as determined by the number and percentage of subjects who develop Adverse Events in each group elicited by a questionnaire administered at specific visits and by hematology, blood chemistry and physical examinations.

Primary efficacy objective:

• To assess the percentage of subjects who normalize their total and direct bilirubin in each group.

Secondary Objective:

To assess the percentage of subjects in each group who:

• Normalize their liver enzymes, i.e. alanine aminotransferase (ALT), aspartate aminotransferase (AST) and inflammatory reactants, i.e. erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).
• 
  Sponsor: University of Maryland
  

  Current Primary Outcome:

  • Incidence, severity and duration of Adverse Events [ Time Frame: Four weeks after enrollment ]
  • Normalization of total (<1.0 mg/dl) and direct bilirubin (<0.3 mg/dl) [ Time Frame: Four weeks after enrollment ]
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • Normalization of ALT, AST, CRP and ESR [ Time Frame: Four weeks after enrollment ]
  • Symptom resolution & return to normal physical activity [ Time Frame: Eight weeks after enrollment ]
  • In AVH patients with specific etiologies resolution of clinical signs and symptoms [ Time Frame: Eight weeks after enrollment ]
  • Persistence of acute HCV with progression to chronicity [ Time Frame: Up to 6 months after enrollment ]
  
  
  

  Original Secondary Outcome:

  • Normalization of ALT, AST, CRP and ESR [ Time Frame: Eight weeks after enrollment ]
  • Symptom resolution & return to normal physical activity [ Time Frame: Eight weeks after enrollment ]
  • In AVH patients with specific etiologies resolution of clinical signs and symptoms [ Time Frame: Eight weeks after enrollment ]
  • Persistence of acute HCV with progression to chronicity [ Time Frame: Up to 12 months after enrollment ]
  
  
  Information By: University of Maryland
  

  Dates:
  Date Received: September 17, 2008
  Date Started: October 2008
  Date Completion:
  Last Updated: June 7, 2016
  Last Verified: June 2016