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Herbal Treatment of Hepatitis C in Methadone Maintained Patients

NCT ID: NCT00010816

Last Updated: 2006-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2003-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Herbal remedies

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Jeff Albrecht, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin County Medical Center, Minneapolis

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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P50AT000009-02

Identifier Type: NIH

Identifier Source: secondary_id

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P50AT000009-03

Identifier Type: NIH

Identifier Source: secondary_id

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P50AT000009-02P3

Identifier Type: NIH

Identifier Source: org_study_id

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NCT00009464

Identifier Type: -

Identifier Source: nct_alias