None listed
Conditions
Interventions
Drug : 1. Hepadif capsule treatment group
1) Hepadif capsule
578.25mg/cap., 1cap. tid, peroral
2) Legalon capsule placebo
426mg/cap., 1cap. tid, peroral
2. Legalon capsule treatment group
1) Legalon capsule
426mg/cap., 1cap. tid, peroral
2) Hepadif capsule placebo
578.25mg/cap., 1cap. tid, peroral
Sponsors
Celltrion Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age at least 19 years and under 70 years 2. Among the subjects with abnormalities of liver function for over three months historically, subjects should be meet the below condition within two weeks prior to study entry; 1) 45U/L=ALT=225U/L 3. Informed consent
Exclusion criteria
Exclusion criteria: 1. Subject with allergy to study agents or their formulations 2. Subject with current viral hepatitis(HAV, HBV, HCV, etc.) or other liver injury that affects study results 3. Subject with Child-Pugh Class B or C decompensated liver cirrhosis 4. Subject who had an experience of surgery such as liver carcinoma or malignant tumor within 6 months prior to study entry 5. Subject who has taken psychotropic medication for the treatment of major depressive disorders prior to study entry 6. Subject with active bleeding 7. Subject with acute bacterial infection 8. Subject with cardiopathy such as below severe heart diseases within 6 months prior to study entry 1) coronary artery bypass, blood vessel stents 2) acute myocardiac infarction 3) angina 4) congestive heart failure 5) unmodulated hypertension(BP > 180/110 mmHg) 6) unmodulated ventricular arrhythmia or arrhythmia requiring continuous treatment 7) severe biliary obstruction (jaundice levels > 3mg/dL) 9. Subject with whole body disorder that affects daily life(eg. COPD, chronic obstructive pulmonary disease) 10. Pregnant or breastfeeding women 11. Subject who participated in any clinical studies within 90 days prior to study entry 12. Subject with unable and unwilling to comply with the informed consent process, to meet study requirements including following insturctions on study treatment, and to return for follow-up visits are required by the protocol. 13. An illiterate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of ALT normalization | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of quality of life (CLDQ, chronic liver disease questionnaire);The change of fatty liver;The change of cognitive function (PHES, psychometric hepatic encephalopathy score);The change of fatigue (CFF, critical flicker frequency);The change of liver function and metabolic parameters;Safety evaluation (adverse event, vital sign, laboratory test etc.) | — |
Countries
Korea, Republic of
Contacts
Public ContactJun Won
Hanyang University
Outcome results
None listed