The efficacy of hepatotonic drugs in several prescription patterns for the liver disease patients with elevated liver enzyme levels: a retrospective, comparative, phase IV study
Not Applicable
Active, not recruiting
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0004280
- Lead Sponsor
- Celltrion Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 906
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
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the normalization rate of ALT
- Secondary Outcome Measures
Name Time Method 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