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Randomized Placebo-controlled Trial Evaluating the Safety and Efficacy of Silymarin Treatment in Patients With Acute Viral Hepatitis

NCT00755950 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-04-23

No results posted yet for this study

Summary

The purpose of this study is to assess whether two higher doses (280mg or 420mg three times daily)of silymarin therapy are safe and tolerable, and shorten the illness in patients with acute viral hepatitis compared to placebo.

Conditions

  • Acute Hepatitis A
  • Acute Hepatitis B
  • Acute Hepatitis C
  • Acute Hepatitis E
  • Acute EBV Hepatitis
  • Acute CMV Hepatitis

Interventions

DIETARY_SUPPLEMENT

Silymarin

280 mg three times daily for four weeks

DIETARY_SUPPLEMENT

Silymarin

420 mg three times daily for four weeks

OTHER

Lactose monohydrate

Lactose monohydrate 326.95 mg three times daily for four weeks

Sponsors & Collaborators

  • MADAUS GmbH

    collaborator OTHER

  • The Egyptian Company for Blood Transfusion Services

    collaborator OTHER

  • Tanta Fever Hospital

    collaborator UNKNOWN

  • Banha Fever Hospital

    collaborator OTHER

  • Alexandria University

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Samer El-Kamary, MD, MPH · University of Maryland, College Park

  • George T Strickland, MD, PhD, · University of Maryland, College Park

  • Mohamed Hashem, MD · University of Maryland, College Park

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-11-30
Completion
2015-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00755950 on ClinicalTrials.gov