KCT0004069招募中未知
A 8week, multi-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of SPB-201 on improving liver function
Sungkyunbiotech0 个研究点目标入组 100 人开始时间: 待定最近更新:
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) Adult male and female between 19-75 years
- •2) 45 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) ?-GTP > 180 IU/L
- •4) Subject who more than 3times the upper limit of normal ALP or Platelet = 105/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 or If the drug is newly started or changed due to diabetes within 3 months or in case of using of insulin)
- •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 severe gastrointestinal symptoms such as heartburn, indigestion, etc.
- •19) Subject who is pregnant or has a pregnancy plan during the period of the clinical trial
- •20) Subject who has planned to participate in other clinical trials during the clinical trial study
- •21) Subject who have participated other clinical trials within the past month
- •22) Subject who the opinion investigator make a judgment to be unsuitable
研究者
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