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Herbal Treatment of Hepatitis C in Methadone Maintained Patients

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010816
First received: February 2, 2001
Last updated: August 17, 2006
Last verified: August 2006
  Purpose

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 Intervention Phase
Hepatitis C
Drug: Herbal remedies
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Herbal Treatment of Hepatitis C in Methadone Maintained Patients

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Study Start Date: September 1998
Estimated Study Completion Date: June 2003
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010816

Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Investigators
Principal Investigator: Jeff Albrecht, MD Hennepin County Medical Center, Minneapolis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00010816     History of Changes
Obsolete Identifiers: NCT00009464
Other Study ID Numbers: P50 AT000009-02P3, P50 AT000009-02, P50 AT000009-03
Study First Received: February 2, 2001
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014