Efficacy of Silymarin for Acute Hepatitis

Hepatitis Clinical Trial

Official title:

Efficacy of Silymarin for Treatment of Acute Hepatitis In Egypt: A Randomized, Double-Blinded, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412763
• Other study ID #: H-21829
• Status: Completed
• Phase: Phase 4
• Start date: July 2003
• Est. completion date: October 2005

Study information

• Verified date: April 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

Drug:
• Silymarin (Silybum marianum)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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. .