Control group : LAENNEC subcutaneous injection (4 ml)
Experimental group : LAENNEC intravenous injection (10 ml)
At the time of screening, 19 or 70 years
Those who have been diagnosed with alcoholic or non-alcoholic fatty liver disease
Those who have increased ALT level (Increased ALT level : 60 IU/L ≤ ALT ≤ 200 IU/L)
A person who can complete the signature agreement and comply with clinical trial requirements.
If you have the following disease
Liver cancer or other malignant tumor within 5 years at screening point
Esophageal varix bleeding, hepatic coma, ascites etc. related disease or Child-Pugh Score Class B,C patient within 1 year at screening point
Organs or bone marrow transplant experience
Parallel
LAENNEC (Human Placenta Hydrolysate) IV
DrugIntravenous Injection
LAENNEC (Human Placenta Hydrolysate) SC
DrugSubcutaneous Injection
Change in ALT level relative to baseline at 6 weeks
In order to compare the test groups and control groups, check the ALT change after 6 weeks compared to the baseline. For the 6 week ALT change amount, a civic analysis (ANCOVA) is performed with the ALT level of the base line and the tamed dynasty (alcohol liver disease/non -alcohol liver liver disease) in a covenant. In addition, depending on the normal distribution of the data, the Paired t-test or Wilcoxon's rank test is performed to confirm the difference in the average change in the military.
Change in ALT level relative to baseline at 2, 4 weeks
In order to compare the test groups and control groups, check the ALT change after 2,4 weeks compared to the baseline. For the 2,4 weeks ALT change amount, a civic analysis (ANCOVA) is performed with the ALT level of the base line and the tamed dynasty (alcohol liver disease/non -alcohol liver liver disease) in a covenant. In addition, depending on the normal distribution of the data, the Paired t-test or Wilcoxon's rank test is performed to confirm the difference in the average change in the military.
Change in AST, Total Bilirubin and r-GT level relative to baseline at 2, 4, 6 weeks
In order to compare the test groups and control groups, check the AST, Total Bilirubin and r-GT change after 2,4,6 weeks compared to the baseline. For the 2, 4, 6 weeks AST, Total Bilirubin and r-GT change amount, a civic analysis (ANCOVA) is performed with the ALT level of the base line and the tamed dynasty (alcohol liver disease/non -alcohol liver liver disease) in a covenant. In addition, depending on the normal distribution of the data, the Paired t-test or Wilcoxon's rank test is performed to confirm the difference in the average change in the military.
The rate of ALT normalization at 2, 4, 6 weeks
Check the difference by conducting Chi-Square Test or Fisher's Exact Test for the number and ratio of the ALT normal level at 2, 4, 6 weeks.
The rate of AST normalization at 2, 4, 6 weeks
Check the difference by conducting Chi-Square Test or Fisher's Exact Test for the number and ratio of the AST normal level at 2, 4, 6 weeks.
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