A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of NVP-1702 on improving liver functio
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002927
- Lead Sponsor
- VP Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
1) Male and female subject aged between 19 years and 75 years
2) Subjects with AST(Aspartate Aminotransferase)(GOT) level 45~120U/L or ALT(Alanine Aminotransferase)(GPT) level 45~120U/L
3) Subjects with a body mass index (BMI) of 23 kg / m^2 or more
4) Subjects who agree to participate in the study and sign the informed consent form
1) Subject with liver cirrhosis or hepatoma on ultrasonography
2) Subject with ?-GTP(Gamma Glutamyl Transpeptidase) > 210U/L
3) During the past one month in the drinking lifestyle survey, more than the average male in a week 14-unit, female in a week 7-unit
4) Subject with Alkaline Phosphatase(ALP) = 390U/L or Platelet = 10^5/ul or AFP(a-fetoprotein) > 20 ng/mL
5) Subject diagnosed with viral hepatitis
6) Subject with HBs Ag(Hepatitis C Virus Antibodies) or HCV Ab(Hepatitis C Virus Antibodies) positive in screening test
7) Subject with Albumin = 3.5g/dl or Total Bilirubin = 3 mg/dl
8) Subject with Creatinine = 2.4mg/dL
9) Subject who TSH(Thyroid Stimulating Hormone) = 0.1uU/ml and = 10uU/ml
10) Subject who taking a drug influence of liver function (INH(isoniazid), valproic acid, tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen, diclofenac, the potential to cause liver toxicy.)within 4 weeks
11) Subject taking cholagogues, cholelitholytics, hepatic Protectors, antidotes, detoxifying agents and drugs used in substance dependence within 4 weeks
12) Subject taking the asian herb, Vit(vitamin). E supplement, Liver function improvement and related health supplements within 2 weeks
13) Subject taking the adrenal cortex hormones or sex hormones to the start of the study within 4 weeks
14) Subjects who cannot take a Investigational Product because of heartburn, indigestion and severe gastrointestinal symptoms
15) Pregnant or get the pregnant person during a clinical trial
16) planning to participate in other clinical trial during the clinical trial
17) Who was participated in the clinical trials to the start of the study within a month
18) Investigator this clinical trial the person who are deemed inappropriate
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AST, ALT
- Secondary Outcome Measures
Name Time Method Multidimensional Fatigue Scale(MFS);vital sign