None listed
Conditions
Interventions
Drug : The test participants are categorized into the following two groups by their random assignment, double blind.
Test Group : Carnitine complex (834 mg/tid) for 12 weeks
Controls : Placebo for 1
Sponsors
Kangdong Sacred Heart Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over 19 years of age 2. Individual who consume alcohol more than 40g per day for men and 20g for women 3. Individual who has ADUIT K score over than 20 for men and 10 for women 4. Individual who has their ALT and AST level above than normal range. 5. 40 IU/L =ALT, AST= 400 IU/L and AST/ALT= 1 6. Individual who has their GGT level above than normal range. 7. - GGT ; Men > 71 IU/L, Women > 42 IU/L
Exclusion criteria
Exclusion criteria: 1. Individual who has allergic response to Investigational product 2. Parkinson’s disease patients who are taking Levodopa for treatment 3. Individual who has Maddrey discriminant function score above 32 4. Individual with Portal hypertension complications 5. Individual with hepatorenal syndrome 6. Individual with viral liver diseases, hepatocellular Carcinoma, liver disease from drug-taking or other liver disease which can affect the results of trial. 7. Individual who experienced bacterial hepatitis in recent 6 months 8. Individual with pancreatitis and HIV 9. Individual with cardiac insufficiency, ischemic cardiomyopathy, respiratory failure 10. Individuals who are taking Psychotropic medication except antidepressant 11. Pregnant women, lactating women 12. Individuals who are considered unsuitable by investigators due to other reasons 13. Individual who didn’t consent with Investigator Consent Form 14. Individuals who are unable to follow the introductions regarding the progress of trial for their medical, psychological, social, geographical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT normalization rate | — |
Secondary
| Measure | Time frame |
|---|---|
| ALT normalization rate;Changes in ALT level;Changes in AST, GGT levels;Changes in IL-6 and TNF-a levels;Changes in Lipopolysaccharide(LPS) level;Test for alcohol consumption by Carbohydrate deficient transferrin level(CDT);Changes in quality of life by WHOQOL-BREF survey;Liver fibrosis by Elastography. | — |
Countries
Korea, Republic of
Contacts
Public ContactKIM HYOUNG SU
Kangdong Sacred Heart Hospital
Outcome results
None listed