A human study for evaluation of the effect of Angelica keiskei koidzum on improving hepatic function and satety

KINDSBIOTIX0 个研究点目标入组 88 人开始时间: 待定最近更新: 2019年4月23日

试验速览

暂无简介。

•1) Subject who voluntarily agrees to participate and signs in informed consent form
•2) 20 = Age < 75 years
•3) normal range = GGT(gamma glutamyltranspeptidase)
•4) the upper limit of normal levels?1.5 < one or more of ALT(alanine aminotransferase) or AST( aspartate aminotransferase)
•5) intake of alcohol: male = 210 g / week, female = 105 g / week

•1) alcoholics
•2) Subject with following diseases and past medical history
•? diseases related hepatic function
•? infectious disease, 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
•3) Received organ transplantation or bone marrow transplantation
•4) Be applicable to one or more
•- one or more of AST( aspartate aminotransferase), ALT(alanine aminotransferase), GGT(gamma glutamyltranspeptidase), ALP(alkaline phosphatase), LDH(lactate dehydrogenase) = the upper limit of normal levels(ULN)?3
•- Platelet = 105/mL or a-fetoprotein > 20 ng/mL
•- Albumin =3.0 g/dL or total bilirubin = 3 mg/dL
•- Creatinine = the upper limit of normal levels(ULN)?2
•5) Administration of drugs that affect liver function within 12 weeks before the first visit
•6) Subjects with High quality of the meal
•7) Predicted to use prohibited drugs
•8) Continuous consumption of dietary supplements or oriental medicine within 4 weeks before the
•first visit
•9) Subjects with hypersensitivity to test materials
•10) Participation in other human study within 12 weeks before the first visit
•11) Pregnant or lactating women
•12) Any condition that the principal investigator believes may put the subjects at undue risk

发起方

KINDSBIOTIX