KCT0002928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 NVP-1702 on improving alcoholic liver function
VP Healthcare0 个研究点目标入组 100 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
- 100
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
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Male and female subject aged between 19 years and 75 years
- •2) Subjects with ?-GTP(Gamma Glutamyl Transpeptidase) level 75~210U/L
- •3) 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
- •4) Subjects who agree to participate in the study and sign the informed consent form
排除标准
- •1) Subject with liver cirrhosis or hepatoma on ultrasonography
- •2) Subject with AST(Aspartate Aminotransferase)(GOT) level or ALT(Alanine Aminotransferase)(GPT) level > 120U/L
- •3) Subject with Alkaline Phosphatase(ALP) = 390U/L or Platelet = 10^5/ul or AFP(a-fetoprotein) > 20 ng/mL
- •4) Subject diagnosed with viral hepatitis
- •5) Subject with HBs Ag(Hepatitis B surface antigen) or HCV Ab(Hepatitis C Virus Antibodies) positive in screening test
- •6) Subject with Albumin = 3.5g/dl or Total Bilirubin = 3 mg/dl
- •7) Subject with Creatinine = 2.4mg/dL
- •8) Subject who TSH(Thyroid Stimulating Hormone) = 0.1uU/ml and = 10uU/ml
- •9) Subject who taking a drug influence of liver function (INH(isoniazid), valproic acid, tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen, diclofenac, the potential to cause liver toxicy.)within 4 weeks
- •10) Subject taking cholagogues, cholelitholytics, hepatic Protectors, antidotes, detoxifying agents and drugs used in substance dependence within 4 weeks
- •11) Subject taking the asian herb, Vit(vitamin). E supplement, Liver function improvement and related health supplements within 2 weeks
- •12) Subject taking the adrenal cortex hormones or sex hormones to the start of the study within 4 weeks
- •13) Subjects who cannot take a Investigational Product because of heartburn, indigestion and severe gastrointestinal symptoms
- •14) Pregnant or get the pregnant person during a clinical trial
- •15) planning to participate in other clinical trial during the clinical trial
- •16) Who was participated in the clinical trials to the start of the study within a month
- •17) Investigator this clinical trial the person who are deemed inappropriate
研究者
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