Herbal Treatment of Hepatitis C in Methadone Maintained Patients

Hepatitis C Clinical Trial

Official title:

Herbal Treatment of Hepatitis C in Methadone Maintained Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00010816
• Other study ID #: P50 AT000009-02P3
• Secondary ID: P50AT000009-02P5
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2001
• Last updated: August 17, 2006
• Start date: September 1998
• Est. completion date: June 2003

Study information

• Verified date: August 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00009464

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Herbal remedies

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,