clinical trial for the evaluation of the efficacy and safety of IBT-Pr on improving liver functio
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0003871
- Lead Sponsor
- Insect Biotch
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
1) Male and female subject aged between 20 years and 75 years
2) Subject with abnormal serum AST(GOT) level 45-135U/L or ALT(GPT) level 40-120U/
1) Subject who are taking treatment(hospitalization, medication, rehabilitation) due to alcohol abuse, alcohol-related disease, heart disease and central nervous disorder
2) Subject with liver cirrhosis or hepatoma on ultrasonography
3) During the past one month in the drinking habit survey, more than the average male in a week 14unit, female in a week 7unit
4) Subjects with ?-GTP(Gamma Glutamyl Transpeptidase) = the upper limit of normal levels(ULN)?4
5) ALP = the upper limit of normal levels(ULN)?3 or Platelet = Platelet 105/µL or AFP > 20ng/mL
6) Subject who currently diagnosed with viral hepatitis
7) Subject who has positive with HBs Ag or HCV Ab in screening
8) Albumin = 3.5g/dl or Total Bilirubin = 3mg/dl
9) Subject who took a medication that affects the liver funtion, Cholagogues, Cholelitholytics, Hepatic Protectors, Antidotes, Detoxifying Agents & Drugs Used in Substance Dependence, adrenal cortical hormone or sex hormone within 4 weeks
10) Subject who took an antiviral agent, antibiotics, oriental medicine, vitamine E supplement or health functional food related with liver function improvement within 2weeks
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AST(Aspartate Transaminase), ALT(Alanine Transaminase), ?-GTP(Gamma Glutamyl Transpeptidase);AST/ALT ratio;Multidimensional fatigue scale;Blood lipids(total cholesterol, Triglyceride, High density lipoprotein cholesterol, Low density lipoprotein cholesterol)
- Secondary Outcome Measures
Name Time Method Adverse event, clinical lab, vital sign, body weight