Hepatitis C (HCV) is a chronic viral illness leading to progressive liver damage that has emerged as a major public health issue in the United States. While HCV affects all population groups, individuals with a history of intravenous drug use form the largest known risk group. Between 90 and 100 percent of long term intravenous drug use will eventually test positive for HCV, and there is substantial risk that even short term experimentation will result in infection. Studies suggest that HCV will be the major cause of cirrhosis and liver cancer in the next century. Currently, approved therapy includes recombinant interferons, which lead to sustained remission in a minority of patients. However, patients abusing other substances, including alcohol, are not eligible for interferon therapy. The need for investigation into other potential therapies is clear. Current practice patterns in the Far East include the use of traditional herbal remedies for symptomatic chronic viral hepatitis. This study is intended to examine the effect of commonly used herbal remedies for the treatment of symptomatic HCV.

Condition	Treatment or Intervention	Phase
Hepatitis C	Drug: Herbal remedies	Phase II

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• English speaking/reading
• Serum positive for HCV virus by PCR
• Elevated alanine transferase (ALT) within 6 months of the Entry Visit, unattributable to causes other than HCV
• Liver biopsy within 2 years of entry confirming that the histological diagnosis is consistent with chronic HCV
• Laboratory parameters available at the Entry Visit including CBC, differential, and platelet count.

Minnesota
      Hennepin County Medical Center, Minneapolis,  Minnesota,  United States

Study chairs or principal investigators

Jeff Albrecht, MD,  Principal Investigator,  Hennepin County Medical Center - Minneapolis   

Study ID Numbers:  8 P50 AT00009-02P3; 8 P50 AT00009-02; 5 P50 AT00009-03
Record last reviewed:  April 2002
Last Updated:  October 13, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010816
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08