Chronic hepatitis C or NAFLD/NASH
Conditions
Interventions
Use of electric therapy apparatus CH-001 for 60 min/treatment, 3 times/day, 8 weeks.
Use of placebo for 60 min/treatment, 3 times/day, 8 weeks.
Sponsors
Kyoundo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with chronic hepatitis C or NAFLD/NASH and with/without cirrhosis 2) Serum ALT at screening: 61 iU/L and higher
Exclusion criteria
Exclusion criteria: [All subjects] 1) Decompensated cirrhosis 2) Other hepatitis virus infections 3) HIV positive 4) Serious chronic bacterial infections 5) Malignant tumour 6) Autoimmune hepatic disorders 7) Alcoholic hepatic disorders or daily alcoholic intake of more than 20g/day 8) Drug-induced hepatic disorders 9) Fulminant hepatitis 10) Biliary disorders 11) Cardiac, renal, or spleen complications requiring hospitalized therapy 12) Sensory disorders due to severe peripheral circulatory disorders 13) During pregnancy/breast feeding, presenting signs of pregnancy, or planning to be pregnant 14) Anti-oxidative therapy within 4 weeks before screening 15) Implantable medical electronics (MEs), life-sustaining MEs, or body-worn MEs [HepC] 1) Interferon and/or ribavirin therapy within 26 weeks before screening 2) Therapy with choleretics, glycyrrhizin compounds, or others within 4 weeks before screening [NAFLD/NASH] 1) Start of therapy with insulin sensitizers, lipid lowering drugs, or others within 4 weeks before screening 2) Start of dietary and/or exercise therapy within 4 weeks before screening 3) Surgical treatments for severe obesity within 4 weeks before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT after 8-week treatment | — |
Countries
Japan
Outcome results
None listed