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

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01292161
First received: February 8, 2011
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Hepatitis C
 Drug: Silymarin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Silymarin for Improving Hepatitis C

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Isfahan University of Medical Sciences:

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


Enrollment: 55
Study Start Date: March 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Silymarin
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292161

Locations
Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: hamid kalantari, A.Professor Associate Professor,Gasteroentrology department
  More Information

Additional Information:
Isfahan university of medical sciences  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01292161     History of Changes
Other Study ID Numbers: ASD-1213-15
Study First Received: February 8, 2011
Last Updated: February 8, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
Hepatitis C
Silymarin
Quality of life

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013