KCT0004392招募中未知
A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of NIHHS-18-42458 on improving liver function
ational Institute of Horticultural and Herbal Science0 个研究点目标入组 90 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
- 90
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) Adult male and female between 19-75 years 2) 50 IU/L =
- •AST or ALT = 120 IU/L 3) Subject who voluntarily agrees to participate and sign
- •in informed consent form
排除标准
- •1) Subject who are admitted to hospital, medication or
- •rehabilitation due to alcohol use disorder ? related disorder, heart disease,
- •central nervous disorder, etc 2) Abdominal ultrasound exam showed liver
- •cirrhosis or liver cancer patients 3) Subject who more than 3times the upper
- •limit of normal ?-GTP 4) Subject who more than 3times the upper limit of normal
- •ALP or Platelet = 10^5/µL or AFP > 10ng/mL 5) Subject who have been diagnosed
- •with viral hepatitis 6) Subjcet who were positive HBs Ag or HCV Ab in screening
- •test 7) Subject who Albumin = 3g/dl or Total Bilirubin = 3mg/dl 8) Subject who
- •more than 1.5times the upper limit of normal Creatinine 9) Uncontrolled thyroid
- •disease patient 10) Subject who was taking drugs the affects liver function
- •within 4 weeks of study(antituberculosis drugs, anticonvulsants, arthrifuges,
- •antidepressants and other drugs that may cause hepatotoxicity) 11) Subject who
- •was taking NSAIDs, antiviral agents, antibiotics within 2 weeks of study 12)
- •Subject who was taking cholagogues, Cholelitholytics & Hepatic Protectors,
- •antidotes, Detoxifying Agents & Drugs Used in Substance Dependence within 4
- •weeks of study 13) Subject who was taking herbal medicine, Vitamine.E
- •supplements, and health functional foods related to liver function improvement
- •within 2 weeks of study 14) Subject who was taking corticosteroids or sex
- •hormones within 4 weeks of study 15) Patients with uncontrolled
- •hypertension(systolic BP = 160 mmHg or diastolic BP = 100 mmHg, measurement
- •after stabilization for 10 minutes of test subjects 16) Uncontrolled
- •diabetic(fasting blood glucose = 180mg/dl) 17) Subject who have dosed
- •Anti-phospholipid drugs within 3 months (They can participate if they have been
- •on treatment since 3 months) 18) Subject who have immoderate drinking habits 19)
- •Subject who have severe gastrointestinal symptoms such as heartburn,
- •indigestion, etc. 20) Subject who are sensitive or allergic to testing food for
- •this human 21) Subject who is pregnant or has a pregnancy plan during the period
- •of the clinical trial 22) Subject who has planned to participate in other
- •clinical trials during the clinical trial study 23) Subject who have
- •participated other clinical trials within the past month 24) Subject who the
- •opinion investigator make a judgment to be unsuitable
研究者
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