12 weeks, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of GDAC(Golden-Antrodia Camphorata) on improving alcoholic liver functio
- Conditions
- Codes for special purposes
- Registration Number
- KCT0003692
- Lead Sponsor
- Korea University Ansan Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1) Male and female over 20 years old and under 75 years old
2) Those who have ?-GTP(?-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(a-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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?-GTP(?-glutamyl transpeptidase);AST(aspartate aminotransferase), ALT(alanine aminotransaminase);AST/ALT ratio;MFS(Multidimensional Fatigue Scale);blood lipids(TC, TG, HDL-c, LDL-c)
- Secondary Outcome Measures
Name Time Method Adverse Event;Clinical pathology examination(Hematologic /Complete blood cell count examination, Urinalysis);Vital Signs(Blood Pressure, Purse), Body Weight;electrocardiography