Working… Menu
Trial record 2 of 2 for:    "Viral Hepatitis" | "Milk thistle"

Efficacy of Silymarin for Acute Hepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00412763
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : December 18, 2006
Information provided by:
University of Maryland, Baltimore

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis Drug: Silymarin (Silybum marianum) Phase 4

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Silymarin for Treatment of Acute Hepatitis In Egypt: A Randomized, Double-Blinded, Controlled Trial
Study Start Date : July 2003
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Silymarin

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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. .

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00412763

Sponsors and Collaborators
University of Maryland, College Park
Layout table for investigator information
Principal Investigator: George T Strickland, MD, PhD University of Maryland, College Park

Layout table for additonal information Identifier: NCT00412763     History of Changes
Other Study ID Numbers: H-21829
First Posted: December 18, 2006    Key Record Dates
Last Update Posted: December 18, 2006
Last Verified: December 2006
Keywords provided by University of Maryland, Baltimore:
Acute hepatitis
Acute viral hepatitis
Acute nonviral hepatitis
Milk Thistle
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs