A human study to determine effective dose of purple sweet potato extract for investigation of hepatoprotective and antioxidative effects in subject with fatty liver: a randomized, double-blind, placebo-controlled study (Pilot study)

Ewha Womans University0 个研究点目标入组 40 人开始时间: 待定最近更新: 2019年3月11日

试验速览

暂无简介。

•1) Subject who voluntarily agrees to participate and signs in informed consent form
•2) Age: = 20 years
•3) Subject with fatty liver (confirmed by ultrasonography)

•1) BMI = 35kg/m2
•2) Chronic smoker (= 20 cigarettes/d)
•3) Alcohol consumption (men: = 30g/d, women: = 15g/d)
•4) Subject with following diseases and past medical history
•? Related to Liver Function : viral hepatitis, liver dysfunction, serious liver disease, primary biliary cirrhosis, drug-induced liver disease, autoinnune liver disease, inherited liver disease
•? General infectious disease (included tuberculosis), serious CVD, renal disease, thyroid disease, autoimmune disease, malignant tumor, multisystem failure, ulcerative colitis, uncontrolled mental illness, HIV
•5) Received organ transplantation or bone marrow transplantation
•6) Predicted to use prohibited drugs
•7) Administration of drugs that affect liver function within 6 months before the first visit (UDCA, statin, hypolipidemic, hypoglycemic, drugs for chronic liver disease, hypotensive, high-dose of estrogen, betaine, corticosteroids, pioglitazone, rosiglitazone, pentoxifylline, gemfibrozil) or administration of steroid over 14 days
•8) Consumption of dietary supplements or oriental medicine that affect liver function and antioxidative capacity within 8 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