clinical trial for the evaluation of the efficacy and safety of BRB-F on improving liver functio
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002143
- Lead Sponsor
- STR Biotech
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
1) older than 20 years and below 75 years
2) 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
3) abnormal serum AST(GOT) or ALT(GPT) level and below 3-fold and ?-GTP level and below 4-
fold of normal range
4) individuals agreed to participate in the study voluntarily after sufficient explanation regarding
the purpose and content of study
1) alcoholism or drug addiction, heart disease, central nerve system(CNS) disorder
2) liver schirosis or hepatoma on ultrasonography
3) Alkaline Phosphatase(ALP) or lactate dehydrogenase(LDH) > 3-fold of normal range or Platelet < 105/ml or AFP > 20 ng/mL
4) viral hepatitis
5) Hepatitis B surface antigen(HBs Ag) or antibodies to hepatitis C virus(HCV Ab) positive
6) Albumin = 3.5 g/dl or Total Bilirubin = 3 mg/dl
7) Prothrombin time (PT) more than 15 sec or activated partial thromboplastin time (aPTT) more than 45 sec person
8) Creatinine is more than twice of the normal range
9) Thyroid Stimulating Hormone (TSH) less than 0.1 uU/ml or more than 10 uU/ml person
10) A person taking the medications for liver function(INH, valproic acid, tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen, diclofenac) to the start of the study within 4 weeks
11) A person taking the Cholagogues, Cholelitholytics & Hepatic Protectors, Antidotes, Detoxifying Agents & Drugs Used in Substance Dependence to the start of the study within 4 weeks
12) A person taking the asian herb, Liver function improvement and related health supplements
13) A person taking the adrenal cortex hormones or sex hormones to the start of the study within 4 weeks
14) Do not adjust the hypertensive patients(More than 160/100mmHg)
15) Does not regulate blood sugar for diabetics(FBS more than 180mg/dl or Within 3 months if you are diabetes due to starting a new drugs)
16) Within 3 months if you are diabetes due to starting a anti-phospholipid new drugs(If you are administering from 3 months old can participate)
17) Heartburn, indigestion and severe gastrointestinal symptoms of person
18) Pregnant or get the pregnant person during a clinical trial
19) planning to participate in other clinical trial during the clinical trial
20) Who was participated in the clinical trials to the start of the study within a months
21) 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 The change of the AST
- Secondary Outcome Measures
Name Time Method The change of ALT;The change of ?-GTP;The change of AST/ALT ratio;The change of MFS;The change of total cholesterol;The change of triglyceride;The change of HDL-cholesterol;The change of LDL-cholesterol;The change of free fatty acid