A retrospective, observational study to evaluate the effectiveness of Carnitine complex (GODEX®) in patients with nonalcoholic fatty liver disease.
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0003058
- Lead Sponsor
- Celltrion Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 30
1. 19 ~70 years old (Adult over 19 under the age of 70)
2. Subjects who were diagnosed with NAFLD
3. If treated group, subjects who were treated with carnitine complex (824mg PO, TID) for at least 24 weeks form index date
4. If control group, subjects who were not taking hepatotonic medications at least 24 weeks from index dates
1. Chronic alcoholic disease
2. Acute hepatitis A, Viral liver disease, drug induced liver disease, biliary obstruction (Chronic hepatitis B patients without taking antiviral agent are eligible)
3. Subjects who administered oral hypoglycemic agent including insulin.
4. Subjects who administered hyperlipidemia medication, antiobestic medication
5. Subjects who administered hepatotonics except for carnitine complex (Godex cap.)
6. Subjects with progressive diseases such as malignant tumor
7. Subjects accompanying active hemorrhage
8. 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 decline in Fibroscan CAP values
- Secondary Outcome Measures
Name Time Method The changes in ALT, AST level;The decline of liver steatosis in liver ultrasonography;Correlation between changes in Fibroscan CAP values and ALT, AST levels;Correlation between changes in Fibroscan CAP values and blood glucose levels;Correlation between changes in Fibroscan CAP values and lipid parameters;The changes of Hepatic Steatosis Index (HSI);The changes of glycemic control (HbA1c, fasting glucose, fasting insulin);Safety evaluation