Steady-State Pharmacokinetic Interactions of Green Tea Catechins and Silymarin Flavonolignans in Treatment Naïve Patients With Chronic Hepatitis C Infection
Sponsor study identifier
Secondary identifiers
OTHER · University of North Carolinat at Chapel Hill
interventional
28
1 country
1
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
July 2013
Actual (reported)The purpose of this study is to determine if the safety, metabolism, and antioxidant activity of silymarin and green tea extract are changed when they are given in combination to patients with chronic hepatitis C infection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 20, 2009
Actual (reported)November 23, 2009
Actual (reported)April 2013
Actual (reported)July 2013
Actual (reported)To assess the safety and tolerability of coadministered silymarin and green tea extract at different doses in patients with chronic hepatitis C.
November 2009 to September 2012
To characterize the antioxidant effects of silymarin and EGCG administered alone or in combination.
November 2009 to September 2012
capsules, 700 mg, twice daily, 12 days
capsules, 196.5 mg, twice daily, 12 days
University of North Carolina at Chapel Hill- UNC Health Care
Chapel Hill, North Carolina, 27514, United States
Roy L Hawke, PhD, PharmD
UNC School of Pharmacy
Michael W Fried, MD
University of North Carolina, Chapel Hill
28 participants (actual enrollment reported by the registry).
First Submitted
November 20, 2009
First Posted
November 23, 2009
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 2013
Actual (reported)Study Completion
July 2013
Actual (reported)Last Updated
April 18, 2017
Record last verified: 2014-06
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Source: ClinicalTrials.gov.
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