Efficacy of Silymarin for Acute Hepatitis
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|ClinicalTrials.gov Identifier: NCT00412763|
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : December 18, 2006
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis||Drug: Silymarin (Silybum marianum)||Phase 4|
The study is designed as a double-blinded placebo controlled trial. We compare a 4 week course of therapy with silymarin tablets and a low-dose vitamin preparation (placebo) and then follow-up for a total of 8 weeks to assess treatment response. Outcomes of our randomized controlled trial are improvement in symptoms and signs, normalization of liver functions, time to resuming normal activities, and and sense of well-being. This protocol follows the standard therapeutic care for acute hepatitis except that the patients will receive either a herbal supplement (silymarin), which many patients are taking anyway, or a vitamin placebo.
Freshly collected serum will be tested for anti-HAV IgM, anti-HBc Igm, anti-HBs, HBs Ag, anti-HCV antibody, HCV-RNA, anti-HDV IgM, anti-HEV IgM, CMV and EBV and for alanine aminotransferase (ALT), AST, direct and total bilirubin.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Silymarin for Treatment of Acute Hepatitis In Egypt: A Randomized, Double-Blinded, Controlled Trial|
|Study Start Date :||July 2003|
|Estimated Study Completion Date :||October 2005|
- Primary outcomes were symptoms and signs of acute hepatitis and results of liver function tests on days 3, 5 and 7 in the hospital and in the outpatient clinic at weeks 2, 4, and 8.
- Side-effects and adverse events were ascertained by self-report on days 3, 5 and 7 in the hospital and in the outpatient clinic at weeks 2, 4, and 8. .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412763
|Principal Investigator:||George T Strickland, MD, PhD||University of Maryland|