KCT0001869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 Citrus aurantium extract on improving liver function
utraPharmTech0 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
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Male and female subject aged between 20 years and 75 years
- •2) Subject with abnormal serum AST(GOT) or ALT(GPT) level and less than 3 times the upper limit of normal.
- •3) Subject who agrees to participate in the study and signs the informed consent form
排除标准
- •1) Subject with a history of hospitalization, a medication or rehabilitation therapy to treat alcohol use disorders, alcohol-induced disorders, cardiac disorders and central nervous system diseases
- •2) Subject with cholelithiasis or gallstone
- •3) Subject with liver cirrhosis or hepatoma on ultrasonography
- •4) Subject with Alkaline Phosphatase(ALP) = 3 times the upper limit of normal or Platelet < 105/ml or AFP > 20 ng/mL
- •5) Subject diagnosed with viral hepatitis
- •6) Subject with HBs Ag or HCV Ab positive in screening test
- •7) Subject with Albumin = 3.5g/dl or Total Bilirubin = 3 mg/dl
- •8) Subject with Creatinine = 2 times the upper limit of normal
- •9) Subject taking a drug influence of liver function (INH, valproic acid,tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen, diclofenac etc, 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 any Chinese herbs or health functional foods related to liver function within 2 weeks
- •12) Subject taking an adrenal cortical hormone or sex hormone within 4 weeks
- •13) Subject with uncontrolled hypertension (over 160/100mmHg, when measuring after 10 minutes steady)
- •14) Subject with uncontrolled diabetes mellitus (more than 180mg/dl of fasting glucose or start taking other diabetes medications within 3 months)
- •15) Subject taking a new antihyperlipidemic drug within 3 months. (If a subject is taking an antihyperlipidemic drug before 3 months, the subject can participate in this study.)
- •16) Subject with complaint of severe gastrointestinal symptoms such as heartburn, dyspepsia
- •17) Subject who is pregnant or planning to pregnant within 3 months
- •18) Subject planning to participate in the other clinical study
- •19) Subject participated in any clinical trial within 1 month
- •20) Inappropriate subject decided by the investigator
研究者
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