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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
Sponsor:
Information provided by:
University of Maryland

December 15, 2006
December 18, 2006
December 18, 2006
July 2003
Not Provided
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.
Same as current
No Changes Posted
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. .
Same as current
Not Provided
Not Provided
 
Efficacy of Silymarin for Acute Hepatitis
Efficacy of Silymarin for Treatment of Acute Hepatitis In Egypt: A Randomized, Double-Blinded, Controlled Trial
The overall objective of this project is to assess whether Silymarin therapy shortens illness or prevents complications in patients with acute hepatitis. We will specifically compare responses in acute hepatitis patients treated with Silymarin to those given a control preparation of a vitamin supplements in a double blinded, randomized, placebo-controlled trial.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hepatitis
Drug: Silymarin (Silybum marianum)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
Same as current
October 2005
Not Provided

Inclusion Criteria:

  • Patients admitted to the fever hospital and presenting with symptoms and signs that may be consistent with a diagnosis of acute hepatitis.
  • Recent (<1 month) history of illness.
  • Elevation of ALT > 2.5 normal.
  • At least 13 years old.

Exclusion Criteria:

  • History suggestive of severe drug-induced acute hepatitis.
  • Children 12 years and younger.
  • Pregnant or breastfeeding women
  • Suspected hypersensitivity to Silymarin or vitamin preparations.
  • Evidence of advanced liver disease e.g. history or presence of ascitis, bleeding esophageal varices, and hepatic encephalopathy.
  • Patients who are critically ill, with multisystem failure or cancer.
  • Substance abuse such as IV drugs.
  • Any other conditions, which in the opinion of the investigator would make the patient unsuitable for enrollment or could interfere with the patient's participation in and completion of the protocol.
Sexes Eligible for Study: All
13 Years to 70 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00412763
H-21829
Not Provided
Not Provided
Not Provided
Not Provided
University of Maryland
Not Provided
Principal Investigator: George T Strickland, MD, PhD University of Maryland
University of Maryland
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP