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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