The efficacy of carnitine complex(The efficacy of carnitine complex(GODEX ? R ) for the patients with moderate alcoholic liver disease: a multicenter, randomized, double blind, phase ? study
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002729
- Lead Sponsor
- Kangdong Sacred Heart Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 38
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/
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ALT normalization rate
- Secondary Outcome Measures
Name Time Method 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.