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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00755950
Other study ID # HP-00042363
Secondary ID LE13K0.48
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date October 2008
Est. completion date December 2015

Study information

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

Clinical Trial 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.


Description:

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Study Design


Intervention

Dietary Supplement:
Silymarin
280 mg three times daily for four weeks
Silymarin
420 mg three times daily for four weeks
Other:
Lactose monohydrate
Lactose monohydrate 326.95 mg three times daily for four weeks

Locations

Country Name City State
Egypt Alexandria University Hospital Alexandria Alexandria Governorate
Egypt Banha Fever Hospital Benha Kaluobeya Governorate
Egypt Tanta Fever Hospital Tanta Gharbeya Governorate

Sponsors (6)

Lead Sponsor Collaborator
University of Maryland, Baltimore Alexandria University, Banha Fever Hospital, MADAUS GmbH, Tanta Fever Hospital, The Egyptian Company for Blood Transfusion Services

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence, severity and duration of Adverse Events Four weeks after enrollment
Primary Normalization of total (<1.0 mg/dl) and direct bilirubin (<0.3 mg/dl) Four weeks after enrollment
Secondary Normalization of ALT, AST, CRP and ESR Four weeks after enrollment
Secondary Symptom resolution & return to normal physical activity Eight weeks after enrollment
Secondary In AVH patients with specific etiologies resolution of clinical signs and symptoms Eight weeks after enrollment
Secondary Persistence of acute HCV with progression to chronicity Up to 6 months after enrollment
See also
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Completed NCT02000063 - Australian Trial in Acute Hepatitis C Recall Study N/A
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