None listed
Conditions
Interventions
None listed
Sponsors
Celltrion Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. over 19 year old on the index date the first treated hepatotonic drugs 2. Subjects who were treated hepatotonic drugs for over then 12 weeks and meet the following criteria 1) Godex cap.: over then 168 cap/12 weeks 2) Ursa tab.: over then 16,800 mg/12 weeks 3) Legalon cap.: over then 168 cap/12 weeks 4) Pennel cap.: over then 168 cap/12weeks 3. outpatient 4. Subjects who meet the hepatic function index (40 IU/L = ALT = 400 IU/L and AST = 400 IU/L)
Exclusion criteria
Exclusion criteria: 1) Subjects with hepatic cirrhosis or malignancy 2) Subjects with HBV, HCV(who weren’t treated anti-virus therapy, could be included) 3) Subjects who administered hepatotonic drugs within 14 days of the index date 4) Other subjects who are not eligible for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the normalization rate of ALT | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in hepatic function index (ALT, AST, ALP, GGT, Total bilirubin, Albumin);The changes in lipid parameters (Total cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol);The changes in blood glucose parameters (Fasting glucose, Fasting insulin, HbA1c);Blood coagulation level (PT, aPTT);The changes in other complete blood cell counts;The changes in weight and BMI;The changes in liver disease parameters;Safety assessment | — |
Countries
Korea, Republic of
Contacts
Public Contactyoung ju
Celltrion Pharm
Outcome results
None listed