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Efficacy of Silymarin for Acute Hepatitis

This study has been completed.
Sponsor:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00412763
First received: December 15, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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 Intervention Phase
Hepatitis
 Drug: Silymarin (Silybum marianum)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Silymarin for Treatment of Acute Hepatitis In Egypt: A Randomized, Double-Blinded, Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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:
  • 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. .

Estimated Enrollment: 200
Study Start Date: July 2003
Estimated Study Completion Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   13 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412763

Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: George T Strickland, MD, PhD University of Maryland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00412763     History of Changes
Other Study ID Numbers: H-21829
Study First Received: December 15, 2006
Last Updated: December 15, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Acute hepatitis
Acute viral hepatitis
Acute nonviral hepatitis
Silymarin
Milk Thistle

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013