Efficacy of Silymarin for Acute Hepatitis

NCT ID: NCT00412763

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2005-10-31

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.

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.

Conditions

Hepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Silymarin (Silybum marianum)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Samer S. El-Kamary

Adjunct Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George T Strickland, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Other Identifiers

H-21829

Identifier Type: -

Identifier Source: org_study_id