Ignite Creation Date:
2024-05-05 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00755950
Status:
TERMINATED
Last Update Posted:
2021-04-23
First Post:
2008-09-17
Brief Title:
Randomized Placebo-controlled Trial Evaluating the Safety and Efficacy of Silymarin Treatment in Patients With Acute Viral Hepatitis
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Multicentre Double-blind Randomized Placebo-controlled Phase IIIII Study to Evaluate the Safety and Efficacy of 280 mg and 420 mg Silymarin TID Legalon Capsules Administered for Four Weeks in Subjects With Acute Viral Hepatitis With a Four Week Follow-up Period
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess whether two higher doses 280mg or 420mg three times dailyof silymarin therapy are safe and tolerable and shorten the illness in patients with acute viral hepatitis compared to placebo
Detailed Description:
Currently acute viral hepatitis AVH management is based on diet and rest and silymarin remains among the most popular herbs being used for treating viral hepatitis both in the US and abroad Although numerous randomized clinical trials have been conducted to assess the efficacy of silymarin on chronic hepatitis C very few studies were done to assess the efficacy of silymarin in acute viral hepatitis Among those efficacy of silymarin has not been established This could be attributed to the small number of studies conducted small sample sizes high drop out rates and low doses of silymarin used Therefore it is justified to evaluate silymarin safety and efficacy using higher doses than previously studied in AVH
Primary safety objective
To assess safety and tolerability of two silymarin doses in patients with AVH as determined by the number and percentage of subjects who develop Adverse Events in each group elicited by a questionnaire administered at specific visits and by hematology blood chemistry and physical examinations
Primary efficacy objective
To assess the percentage of subjects who normalize their total and direct bilirubin in each group
Secondary Objective
To assess the percentage of subjects in each group who
Normalize their liver enzymes ie alanine aminotransferase ALT aspartate aminotransferase AST and inflammatory reactants ie erythrocyte sedimentation rate ESR and C-reactive protein CRP
Resolve their clinical symptoms of AVH and return to baseline activity levels and quality of life QOL assessed by physical examinations and using a previously evaluated Arabic-translated SF-36 form adapted for use with patients with liver diseases
To assess
Differences in silymarin response in different AVH etiologies ie HAV HBV HCV HEV using subgroup analyses
To compare
Progression of acute to chronic HCV infection in subjects with HCV-caused acute AVH
Primary safety objective
To assess safety and tolerability of two silymarin doses in patients with AVH as determined by the number and percentage of subjects who develop Adverse Events in each group elicited by a questionnaire administered at specific visits and by hematology blood chemistry and physical examinations
Primary efficacy objective
To assess the percentage of subjects who normalize their total and direct bilirubin in each group
Secondary Objective
To assess the percentage of subjects in each group who
Normalize their liver enzymes ie alanine aminotransferase ALT aspartate aminotransferase AST and inflammatory reactants ie erythrocyte sedimentation rate ESR and C-reactive protein CRP
Resolve their clinical symptoms of AVH and return to baseline activity levels and quality of life QOL assessed by physical examinations and using a previously evaluated Arabic-translated SF-36 form adapted for use with patients with liver diseases
To assess
Differences in silymarin response in different AVH etiologies ie HAV HBV HCV HEV using subgroup analyses
To compare
Progression of acute to chronic HCV infection in subjects with HCV-caused acute AVH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LE13K048 | None | None | None |