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Safety, Metabolism, and Antioxidant Activity of Silymarin and Green Tea Extract in Patients With Chronic Hepatitis C

NCT01018615 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-04-18

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Hepatitis C
  • Oxidative Stress

Interventions

DRUG

silymarin

capsules, 700 mg, twice daily, 12 days

DIETARY_SUPPLEMENT

green tea extract (EGCG)

capsules, 196.5 mg, twice daily, 12 days

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Roy L Hawke, PhD, PharmD · UNC School of Pharmacy

  • Michael W Fried, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-04-30
Completion
2013-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01018615 on ClinicalTrials.gov