Status:

COMPLETED

Efficacy of Silymarin for Acute Hepatitis

Lead Sponsor:

University of Maryland, Baltimore

Conditions:

Hepatitis

Eligibility:

All Genders

13-70 years

Phase:

PHASE4

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 acut...

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 t...

Eligibility 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.

Key Trial Info

Start Date :

July 1 2003

Trial Type :

INTERVENTIONAL

End Date :

October 1 2005

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00412763

Start Date

July 1 2003

End Date

October 1 2005

Last Update

April 23 2021

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