SHO-SAIKO-TO for Patients With Chronic Hepatitis C: A Phase II Study
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Sho-saiko-to
Intervention description: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks unless occurrence of unacceptable adverse events or patient withdrawal. Patients will be seen for clinical follow-up at three month intervals: at 3, 6, 9, and 12 months, and assessed for compliance and asked about side effects and pulmonary symptoms. At each clinic visit, a comprehensive metabolic profile will be performed. At the 6-month clinic visit, a CBC will be performed. At the 12-month clinic visit, quantitative HCV-RNA by PCR will be obtained (Viromed Labs, Inc., 6101 Blue Circle Drive, Minneapolis, MN 5534). Within 4 weeks after the 12-month clinic visit (after 52 weeks of SST therapy), the second liver biopsy will be scheduled and performed.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C; Sho-saiko-to; SST; Interferon Therapy

Summary:

      Researchers want to see whether Sho-saiko-to (SST) can help in patients with chronic
      hepatitis C. Chronic hepatitis C may cause swelling within the liver and this can lead to
      scar tissue. In some patients, severe scarring of the liver, liver failure and liver cancer
      can occur. Standard treatment for chronic hepatitis C is a drug called interferon with or
      without another drug called ribavirin. There are a number of side effects that some patients
      are unable to take. Other patients may have an initial response, but then the virus and the
      inflammation come back.

      Sho-saiko-to is an herbal medicine that has been used for many years in Asia to treat liver
      disease. The purpose of the study is to evaluate whether Sho-saiko-to may improve liver
      swelling and injury caused by chronic hepatitis C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis C diagnosis, with abnormal liver function tests, positive serology
             for Hepatitis C antibody, positive viremia as indicated by PCR techniques.

          -  Age 18 or over

          -  There must be no plans to use interferon in the following 12 months due to EITHER: a
             specific contraindication to interferon therapy, including but not limited to:history
             of depression, or other psychiatric disease, history of autoimmune disease,psoriasis,
             rheumatoid arthritis, history of renal dysfunction, thyroid abnormalities, seizure
             disorder, depressed blood cell counts, history of asthma OR patient discontinuation of
             interferon-based therapy prematurely due to intolerable side effects with sustained
             active viremia OR patient refusal to take interferon

          -  Patients must be able to understand and sign informed consent.

          -  Female participants must agree to practice approved methods of birth control (if
             applicable).

        Exclusion Criteria:

          -  Coinfection with hepatitis B as defined by a positive Hepatitis B surface antigen
             (HBsAg) test.

          -  Coinfection with HIV

          -  Patients with alcohol intake >40g day

          -  Patients with recent myocardial infarction or heart failure.

          -  Concurrent use of Sho-saiko-to, or any of its constituent plants.

          -  Concurrent use of interferon containing products.

          -  Use of interferon-based treatment within the past 6 months.

          -  Women who are pregnant, nursing, or have the potential to becoming pregnant, unless
             utilizing birth control. A negative pregnancy test must be documented during the
             screening period for women of childbearing potential.

          -  History of malignancy, unless there is currently no evidence of disease and patient
             completed all surgery, radiotherapy and chemotherapy for that disease a minimum of two
             years previously

          -  Concurrent life-threatening illness, for which the prognosis is poor.

          -  Patients with diffusing capacity on pulmonary testing less than 50% of predicted will
             be excluded.

          -  Patients with diffusing capacity on pulmonary testing less than 70% of predicted AND
             total lung capacity less than 80% of predicted will be excluded.