Herbal Treatment of Hepatitis C in Methadone Maintained Patients

NCT00010816 | Completed Phase 2

• 3 other identifiers: P50AT000009-02P3P50AT000009-02P50AT000009-03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Interventions

Herbal remedies DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Jeff Albrecht, MD

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: February 5, 2001
• Study Start: September 1, 1998
• Study Completion: June 1, 2003
• Last Updated: August 18, 2006

Record last verified: 2006-08

Locations

US (1)