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Completed

NCT Number: NCT01292161

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

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

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al-zahra university hospital

Isfahan, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silymarin

Drug

Tab 210 mg, 630 mg, daily, six months.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Study of Silymarin for Improving Hepatitis C

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 9, 2011
Registry last updated
Feb 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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