Herbal Treatment of Hepatitis C in Methadone Maintained Patients
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Herbal remedies
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility 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.
Sites / Locations
- Hennepin County Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00010816
First Posted
February 2, 2001
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00010816
Brief Title
Herbal Treatment of Hepatitis C in Methadone Maintained Patients
Official Title
Herbal Treatment of Hepatitis C in Methadone Maintained Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Herbal remedies
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Albrecht, MD
Organizational Affiliation
Hennepin County Medical Center, Minneapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Herbal Treatment of Hepatitis C in Methadone Maintained Patients
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