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.
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). * Resolve their clinical symptoms of AVH and return to baseline activity levels and quality of life (QOL) assessed by physical examinations and using a previously evaluated Arabic-translated SF-36 form adapted for use with patients with liver diseases. To assess: * Differences in silymarin response in different AVH etiologies (i.e. HAV, HBV, HCV, HEV) using subgroup analyses. To compare: * Progression of acute to chronic HCV infection in subjects with HCV-caused acute AVH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
70
280 mg three times daily for four weeks
420 mg three times daily for four weeks
Lactose monohydrate 326.95 mg three times daily for four weeks
Alexandria University Hospital
Alexandria, Alexandria Governorate, Egypt
Tanta Fever Hospital
Tanta, Gharbeya Governorate, Egypt
Banha Fever Hospital
Banhā, Kaluobeya Governorate, Egypt
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
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
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