Efficacy of Silymarin for Acute Hepatitis

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Silymarin

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.