- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00010816
Herbal Treatment of Hepatitis C in Methadone Maintained Patients
August 17, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States
- Hennepin County Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeff Albrecht, MD, Hennepin County Medical Center, Minneapolis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1998
Study Completion
June 1, 2003
Study Registration Dates
First Submitted
February 2, 2001
First Submitted That Met QC Criteria
February 2, 2001
First Posted (Estimate)
February 5, 2001
Study Record Updates
Last Update Posted (Estimate)
August 18, 2006
Last Update Submitted That Met QC Criteria
August 17, 2006
Last Verified
August 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis C
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
AbbVieCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 1a
-
AbbVie (prior sponsor, Abbott)CompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV)United States, Australia, Canada, France, Germany, New Zealand, Puerto Rico, Spain, United Kingdom
-
Sohag UniversityRecruiting
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV) | Hepatitis C Viral InfectionUnited States, New Zealand
Clinical Trials on Herbal remedies
-
Fr Muller Homoeopathic Medical CollegeUnknownPolycystic Ovary Syndrome | Menstrual DisordersIndia
-
University of TorontoCentre for Addiction and Mental Health; University of Alberta; SickKids FoundationCompletedAttention Deficit Hyperactivity DisorderCanada
-
Medical University of ViennaCompleted
-
The Hospital for Sick ChildrenCompleted
-
Medical University of ViennaCompleted
-
Jeong-taek WooChonbuk National University Hospital; Samsung Medical Center; Pusan National... and other collaboratorsUnknown
-
Venus Remedies LimitedCompleted
-
Government Dental College and Research Institute...Himalaya Drug Company Research and Development, Makali, Bangalore, IndiaCompletedDentinal Hypersensitivity
-
Medical University of South CarolinaTraditional Medicinals CorporationCompletedLactationUnited States