Back to resultsEffects of Silybum Marianum on Treatment of Patients With Chronic Hepatitis C
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Silymarin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Silymarin, Quality of life
Eligibility Criteria
Inclusion Criteria:
confirmed chronic hepatitis C (HCV Ab (+), HCV RNA (with PCR) (+)) normal or increased liver enzymes (ALT and AST) not using interferon or ribavirin due to patient sensitivity or not consenting.
Exclusion Criteria:
The pregnant patients patients with side effect which confirmed with rechallenge test
Sites / Locations
- Al-zahra university hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Silymarin
Arm Description
Silymarin drived from Silybum marianum (milk thistle), a flowering member of the daisy family, may benefit liver function in people infected with the hepatitis C virus.
Outcomes
Primary Outcome Measures
Serum aminotransferases (ALT, AST)
The investigators measured serum amino transferases by commercial AST kit,. ALT kits(Bayer Diagnostics,. Tarrytown, NY, USA) at six months after silymarin admission
Secondary Outcome Measures
HCV-RNA
The investigators measured serum HCV-RNA by Polymerase Chain Reaction (PCR) at six months after silymarin admission
Full Information
NCT ID
NCT01292161
First Posted
February 8, 2011
Last Updated
February 8, 2011
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01292161
Brief Title
Effects of Silybum Marianum on Treatment of Patients With Chronic Hepatitis C
Official Title
Study of Silymarin for Improving Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the effects of silymarin on outcomes of patients with hepatitis C.
Detailed Description
Silymarin has been claimed to have a beneficial effect in various types of liver injury, including alcoholic liver disease, drug and toxin induced hepatotoxicity, and acute and chronic viral hepatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C, Silymarin, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silymarin
Arm Type
Other
Arm Description
Silymarin drived from Silybum marianum (milk thistle), a flowering member of the daisy family, may benefit liver function in people infected with the hepatitis C virus.
Intervention Type
Drug
Intervention Name(s)
Silymarin
Intervention Description
Tab 210 mg, 630 mg, daily, six months.
Primary Outcome Measure Information:
Title
Serum aminotransferases (ALT, AST)
Description
The investigators measured serum amino transferases by commercial AST kit,. ALT kits(Bayer Diagnostics,. Tarrytown, NY, USA) at six months after silymarin admission
Time Frame
at six months after admission
Secondary Outcome Measure Information:
Title
HCV-RNA
Description
The investigators measured serum HCV-RNA by Polymerase Chain Reaction (PCR) at six months after silymarin admission
Time Frame
at six months after admission
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
confirmed chronic hepatitis C (HCV Ab (+), HCV RNA (with PCR) (+)) normal or increased liver enzymes (ALT and AST) not using interferon or ribavirin due to patient sensitivity or not consenting.
Exclusion Criteria:
The pregnant patients patients with side effect which confirmed with rechallenge test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hamid kalantari, A.Professor
Organizational Affiliation
Associate Professor,Gasteroentrology department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-zahra university hospital
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://mui.ac.ir
Description
Isfahan university of medical sciences
Learn more about this trial
Effects of Silybum Marianum on Treatment of Patients With Chronic Hepatitis C
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