○ Objectives and Background: Fatty liver is divided into nonalcoholic fatty liver disease caused by obesity, diabetes, hyperlipidemia, and alcoholic fatty liver due to excessive alcohol consumption. Liver cholesterol and liver cancer are progressed through liver fibrosis if chronic liver damage is persistent. These liver diseases mainly occur in middle-aged and elderly people, which occupy socially and economically important positions, resulting in a great loss in socially and economically.Thus the necessity and importance of developing a new liver disease therapeutic agent is growing
 This study was designed to evaluate the efficacy and safety of liver function improvement of products compared to placebo when GDAC was ingested.
○ Intervention and Results to be Measured: This study was designed as a 12-week, multicenter, randomized, double-blind, placebo-controlled clinical trial study. The applicant for this study will sign the consent form on his / her own and be registered through the visit evaluation.
 ◎ Primary efficacy evaluation: γ-GTP(γ-glutamyl transpeptidase)
 ◎ 2nd efficacy evaluation:
        1) AST(aspartate aminotransferase), ALT(alanine aminotransaminase)
        2) AST / ALT ratio
        3) Multidimensional Fatigue Scale (MFS)
        4) Blood lipids (TC(Total cholesterol ), TG(Triglyceride), HDL-c(high density lipoprotein cholesterol), LDL-c(low density lipoprotein cholesterol))

 Supportive Care

The subjects who apply to the Clinical trial study are randomly assigned to GDAC 300mg or the investigational drug. Take 1 tablet once a day for 12 weeks.

Arm Label

Target Number of Participant

Arm Type

Arm Description

The subjects are randomly assigned to either GDAC 300 mg or a comparator. One dose once a day, one dose is given orally for 12 weeks.

Arm Label

Target Number of Participant

Arm Type

Arm Description

The subjects are randomly assigned to either GDAC 300 mg or a comparator. One dose once a day, one dose is given orally for 12 weeks.

Gender

Age

Description

1) Male and female over 20 years old and under 75 years old
2) Those who have γ-GTP(γ-glutamyl transpeptidase) in the blood test between 60 and 180 U / L
3) Drinking habits Questionnaire for person who consumed more than 7 units of alcohol per week,
* Male 14unit: 2.3 bottles of shochu, 10.5 cans of beer, 3.5 bottles of makkolli, 2.3 bottles of wine, 14 glasses of wine
  7unit of women: 1.2 bottles of shochu, 5.3 cans of beer, 1.8 bottles of rice wine, 1.2 bottles of wine, 7 bottles of wine
4) Those who have agreed to participate in this study before the commencement of the study and who have written an informed consent

1) Through medical history investigation. · People who are hospitalized, medicated, or rehabilitated due to Alcohol misuse,induced disorder, heart disease, central nervous disorder, etc.
2) Abdominal ultrasound examination showed liver cirrhosis or liver cancer patients
3) A person whose blood test exceeds 150 U / L in AST(aspartate aminotransferase, GOT) or ALT(alanine aminotransaminase, GPT)
4) ALP(Alkaline phosphatase) is more than three times the normal upper limit of the clinical trial site or Platelet 105 / μL or more than 20 ng / mL of AFP(α-fetoprotein)
5) Those who have been diagnosed with viral hepatitis
6) Those who were positive on screening test for HBsAg(Hepatitis B surface antigen) or HCV Ab(Hepatitis C Virus Antibody)
7) Albumin Not more than 3.5 g / dl or Total bilirubin not less than 2.0 mg / dl
8) Creatinine is at least twice the normal upper limit
9) Those with TSH(thyroid stimulating hormone) less than or equal to 0.1 μU / ml, or greater than or equal to 10 μU / ml
10) Those taking medication that affects liver function within 4 weeks of study(anti-tuberculosis drugs, anticonvulsants, gout remedies, antidepressants, NSAIDs(Non-steroidal anti-inflammatory drugs) and other drugs that may cause hepatotoxicity)
11) Those taking antiviral drugs and antibiotics within 2 weeks of the start of the study
12) Those taking antidotes, detoxifying agents and drugs used within 4 weeks of taking the test, Cholagogues, Cholelitholytics & Hepatic Protectors, Antidotes, Detoxifying Agents and Drugs Used in Substance Dependence
13) Within two weeks of the start of the study, the Chinese medicine, Vitamine. E Those taking supplements or health functional foods related to liver function improvement
14) Those who have taken corticosteroids or sex hormones within 4 weeks of the start of the study
15) Patients with uncontrolled hypertension (over 160 / 100mmHg, measured after 10 minutes of test subjects)
16) Diabetic patients without controlled blood glucose (fasting blood sugar 180mg / dl or diabetes mellitus in the first 3 months or when insulin is administered intravenously)
17) Those who have dosed Anti-phospholipid drugs within 3 months (They can participate if they have been on treatment since 3 months)
18) People who have severe gastrointestinal symptoms such as heartburn, indigestion, etc.
19) Those who are pregnant or who have a pregnancy plan during the period of the test
20) Those who intend to participate in other clinical trials during the period of the clinical trial study
21) Those who participated in other clinical trials within one month of the start of this clinical trial study
22) A person who is deemed inappropriate by the Principal Investigator

γ-GTP(γ-glutamyl transpeptidase)

6 week, 12 week

AST(aspartate aminotransferase), ALT(alanine aminotransaminase)

6 week, 12 week

AST/ALT ratio

6 week, 12 week

MFS(Multidimensional Fatigue Scale)

baseline, 6 week, 12 week

blood lipids(TC, TG, HDL-c, LDL-c)

baseline, 6 week, 12 week

Adverse Event

6 week, 12 week

Clinical pathology examination(Hematologic /Complete blood cell count examination, Urinalysis)

baseline, 12 week

Vital Signs(Blood Pressure, Purse), Body Weight

baseline, 6 week, 12 week

electrocardiography

baseline, 12 week