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

Hepatitis C Clinical Trial

Official title:

Study of Silymarin for Improving Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292161
• Other study ID #: ASD-1213-15
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2011
• Last updated: February 8, 2011
• Start date: March 2006
• Est. completion date: September 2006

Study information

• Verified date: September 2006
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Silymarin
Tab 210 mg, 630 mg, daily, six months.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-zahra university hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at six months after admission	Yes
Secondary	HCV-RNA	The investigators measured serum HCV-RNA by Polymerase Chain Reaction (PCR) at six months after silymarin admission	at six months after admission	Yes

External Links

•   Isfahan university of medical sciences