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Herbal Treatment of Hepatitis C in Methadone Maintained Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00010816
First Posted: February 5, 2001
Last Update Posted: August 18, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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
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 Integrative Health (NCCIH):

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010816


Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Jeff Albrecht, MD Hennepin County Medical Center, Minneapolis
  More Information

ClinicalTrials.gov Identifier: NCT00010816     History of Changes
Obsolete Identifiers: NCT00009464
Other Study ID Numbers: P50AT000009-02P3 ( U.S. NIH Grant/Contract )
P50AT000009-02 ( U.S. NIH Grant/Contract )
P50AT000009-03 ( U.S. NIH Grant/Contract )
First Submitted: February 2, 2001
First Posted: February 5, 2001
Last Update Posted: August 18, 2006
Last Verified: August 2006

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents