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 alcoholic liver functio

Not Applicable

Recruiting

• Conditions: Diseases of the digestive system

• Registration Number: KCT0002928
• Lead Sponsor: VP Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Male and female subject aged between 19 years and 75 years
2) Subjects with ?-GTP(Gamma Glutamyl Transpeptidase) level 75~210U/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) Subjects who agree to participate in the study and sign the informed consent form

Exclusion Criteria

1) Subject with liver cirrhosis or hepatoma on ultrasonography
2) Subject with AST(Aspartate Aminotransferase)(GOT) level or ALT(Alanine Aminotransferase)(GPT) level > 120U/L
3) Subject with Alkaline Phosphatase(ALP) = 390U/L or Platelet = 10^5/ul or AFP(a-fetoprotein) > 20 ng/mL
4) Subject diagnosed with viral hepatitis
5) Subject with HBs Ag(Hepatitis B surface antigen) or HCV Ab(Hepatitis C Virus Antibodies) positive in screening test
6) Subject with Albumin = 3.5g/dl or Total Bilirubin = 3 mg/dl
7) Subject with Creatinine = 2.4mg/dL
8) Subject who TSH(Thyroid Stimulating Hormone) = 0.1uU/ml and = 10uU/ml
9) 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
10) Subject taking cholagogues, cholelitholytics, hepatic Protectors, antidotes, detoxifying agents and drugs used in substance dependence within 4 weeks
11) Subject taking the asian herb, Vit(vitamin). E supplement, Liver function improvement and related health supplements within 2 weeks
12) Subject taking the adrenal cortex hormones or sex hormones to the start of the study within 4 weeks
13) Subjects who cannot take a Investigational Product because of heartburn, indigestion and severe gastrointestinal symptoms
14) Pregnant or get the pregnant person during a clinical trial
15) planning to participate in other clinical trial during the clinical trial
16) Who was participated in the clinical trials to the start of the study within a month
17) Investigator this clinical trial the person who are deemed inappropriate

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified