clinical trial for the evaluation of the efficacy and safety of BRB-F on improving liver function

A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of BRB-F on improving liver function

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002143

Enrollment

Registered

2016-11-17

Start date

2015-09-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of BRB-F on improving liver function Experiment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

Measure	Time frame
The change of the AST	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactMinjung Kim

Korea University Ansan Hospital

Outcome results