Effects of Sho-saiko-to, a Herbal Formula, in Reducing Viral Load in Hepatitis C

This is an interventional treatment trial for Hepatitis C Virus focused on measuring hepatitis C virus, complementary and alternative medicine, peginterferon alfa and ribavirin Read More

Inclusion Criteria:

• Diagnosed with hepatitis C virus (HCV) genotype 1 with detectable HCV RNA >2000IU/mL at baseline assessment.
• Have relapsed after the standard care peginterferon alfa and ribavirin, or did not respond, or standard care peginterferon alfa and ribavirin contraindicated.
• Age 18 to 65 years
• Gender: male or female
• If female of childbearing potential (uterus has not been removed), willingness to use an approved form of birth control with male sexual partners through entire study and for 3 months after study completion
• Chest x-ray negative for pulmonary disease within 6 months of enrollment

Exclusion Criteria:

• Age < 18 or > 65 years.
• Currently on peginterferon alfa and ribavirin therapy, or have been on this therapy within the past 6 months.
• Currently taking monoamine oxidase inhibitors (MAOIs) for depression or have a serious mental illness.
• Diagnosed with cardiac disease, including severe heart failure, arrhythmia; significant kidney disease; asthma or other obstructive or restrictive pulmonary disease, interstitial pneumonitis and/or hypoxemia, leading to difficulty breathing or shortness of breath; immune-mediated disease (e.g., rheumatoid arthritis, vasculitis).
• Pulmonary function resulting in Forced Expiratory Volume (FEV1) at least 80% predicted.
• Confirmed diagnosis of TB.
• Infected with HIV, hepatitis A, B, D, E, or other viral blood infection (e.g., EBV, CMV)
• Taking anticoagulant therapy or have had anticoagulants within 30 days of enrollment
• Have taken antiviral medications within past 30 days
• Laboratory tests resulting in:
• platelet count ≤100,000/mm3
• serum bilirubin >1.5 g/dL
• Prothrombin Time-International Normalized Ratio (INR) >1.5
• albumin <3.4 g/dL
• hemoglobin <13 g/dL in men, <12 g/dL in women
• Absolute Neutrophil Count (ANC) <1.5 k/dL
• serum creatinine >1.5 mg/dL
• alanine transaminase (ALT) > 10 x baseline
• Hypertension (SBP > 140 or DBP >90)
• Hypokalemia (K < 3.5)
• Liver biopsy results that reveal stage 4 fibrosis (cirrhosis)
• Cirrhosis or at risk for developing hepatocellular carcinoma as evidenced by an elevated AFP test at screening.
• Undergone transplant of any kind and/or taking corticosteroids or other immunosuppressive therapy (or have taken immunosuppressive therapy within the previous 6 months)
• Consuming alcohol.
• Hypersensitivity to any of the 7 components of SST.
• Taking over-the counter products that could potentially interact with the components of SST.
• Have participated in another investigational drug study within the past 60 days.
• Taking anthraquinone drugs or herbs containing anthraquinone
• In a methadone maintenance program.
• Using recreational drugs.
• Pregnant, breastfeeding, or unwillingness to use an approved form of birth control for women of childbearing potential.
• Unable to understand the consent process or study-related questions due to language barriers, cognitive impairment, or other reasons.
• Weigh more than 275 pounds, which could complicate liver biopsy procedures.