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Effects of Silybum Marianum on Treatment of Patients With Chronic Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01292161
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : February 9, 2011
Information provided by:
Isfahan University of Medical Sciences

Brief Summary:
The purpose of this study is to determine the effects of silymarin on outcomes of patients with hepatitis C.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Silymarin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Silymarin for Improving Hepatitis C
Study Start Date : March 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Silymarin

Arm Intervention/treatment
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.
Drug: Silymarin
Tab 210 mg, 630 mg, daily, six months.

Primary Outcome Measures :
  1. Serum aminotransferases (ALT, AST) [ Time Frame: at six months after admission ]
    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 :
  1. HCV-RNA [ Time Frame: at six months after admission ]
    The investigators measured serum HCV-RNA by Polymerase Chain Reaction (PCR) at six months after silymarin admission

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01292161

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Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
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Principal Investigator: hamid kalantari, A.Professor Associate Professor,Gasteroentrology department
Additional Information:
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Responsible Party: Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences Identifier: NCT01292161    
Other Study ID Numbers: ASD-1213-15
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: February 9, 2011
Last Verified: September 2006
Keywords provided by Isfahan University of Medical Sciences:
Hepatitis C
Quality of life
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs