KCT0002143招募中未知
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
STR Biotech0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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