KCT0002988已完成未知
A human study for evaluation of the effect of Theracurmin CR-033P on improving hepatic function and safety; : 12 weeks, multi-center, double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- HANDOK INC
- 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
- 20(Year) 至 74(Year)（—）
- 性别
- All
入选标准
- •1) Subject who voluntarily agrees to participate and signs in informed consent form
- •2) 20 = Age < 75 years
- •3) Subject who has fatty liver
- •4) 40 < one or more of ALT or AST < 120
排除标准
- •1) Subjects with High quality of the meal (recommended food score > 36)
- •2) Subjects who constantly performed severe exercises at least 10 hours per week
- •3) Chronic smoker (= 20 cigarettes/d)
- •4) alcoholics or Subjects who usually drink alcohol as follows
- •-male = 210 g / week (3.5 bottles of soju/week, 4 glasses/day)
- •-female = 140 g / week (2.5 bottles of soju/week, 3 glasses/day)
- •5) BMI: < 23kg/m2 or = 35kg/m2
- •6) Subject with following diseases and past medical history
- •? diseases related hepatic function
- •-viral hepatitis
- •-serious liver disease(hepatic insufficiency, etc.) primary biliary cirrhosis, drug-induced liver disease
- •-autoimmune liver disease
- •-liver disease induced by drug or operation, inherited liver disease
- •? infectious disease (tuberculosis, etc.), serious cardiovascular disease, disease of digestive system, renal disease, thyroid disease, autoimmune disease, malignant tumor, multisystem failure, Inflammatory Bowel Disease, serious mental illness,HIV positive
- •? who has continuous symptom releated with gastrointestinal diseases (brash, dyspepsia etc.)
- •7) Received organ transplantation or bone marrow transplantation
- •8) Be applicable to one or more
- •- AST or ALT = 120 U/L
- •- ALP = the upper limit of normal levels(ULN)?3
- •- Platelet = 105/mL or a-fetoprotein > 20 ng/mL
- •- Albumin =3.3 g/dL or total bilirubin = 3 mg/dL
- •- Creatinine = the upper limit of normal levels(ULN)?2
- •- HbA1c = 7.0%
- •9) Predicted to use prohibited drugs
- •10) Administration of drugs that affect liver function within 12 weeks before the first visit (medication for hyperlipidemia,antidiabetics, high dose of estrogen or administration of steroid over 14 days
- •(but, medication of antihypertensives and antihyperlipidemia(such as statin) is permitted, as long as they had been used at a constant dosage/commenced at least 3 months prior to the study/be expected to maintain the dosage during the study)
- •11) Continuous consumption of dietary supplements or oriental medicine within 4 weeks before the first visit
- •12) Subjects with hypersensitivity to test materials
- •13) Participation in other human study within 12 weeks before the first visit
- •14) Pregnant or lactating women
- •15) Any condition that the principal investigator believes may put the subjects at undue risk
研究者
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