NAFLD/NASH
Conditions
Interventions
Misatol GL twice (6.5g x 2) per day for 8 weeks
Placebo twice (6.5g x 2) per day for 8 weeks
Sponsors
Sanno Medical Center
1.Jntenndo University Hospital 2.The Jikei University Daisan Hospital 3.Tokyo Metropolitan Bokutoh Hospital 4.Kyoundo Hospital 5. Chiba University Hospital 6.Kitaibaraki City Hospital 7.Shibata Hepatology Clinic 8.Toshima Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with hepatic steatosis is suspected by abdominal US, CT or MRI tests. 2. ALT higher than 60 IU/L 3. Patients who are able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have serious liver disease (decompensated cirrhosis (Child-Pugh B<), liver cancer), whose ALT higher than 300 IU/L, or jaundice. 2. Other chronic liver disease (alcoholic liver disease, virus hepatitis, autoimmune hepatitis, metabolic liver disease) 3. Patients who have undergone bariatric surgery. 4. Pregnant woman, lactating woman, or a woman suspected of pregnancy. 5. Patients under insulin treatment. 6. Patients with severe cardiac disease. 7. Patients with severe kidney disease (CRE>2.0 mg/dL). 8. Patients who are unable to comply with administrative matters. 9. Patients who are allergic to the test foods. 10. Patients who have alcohol intake more than 30 g/day for male, and more than 20 g/day for female. 11. Patients who have participated in a clinical trials in the last 3 months. 12. Patients who are currently taking Misatol. 13. Patients who are judged by the investigator not to be appropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum ALT | — |
Countries
Japan
Contacts
Public ContactShiro Ueda
Medical Edge Inc. Sytem Development
Outcome results
None listed