Human study for investigating the effectiveness and safety of black ginseng ethanol extract(GBG05-FF) in adults with impaired fasting glucose

Inje University Seoul Paik Hospital0 个研究点目标入组 80 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 sign in informed consent form
•2) Adults (Age=20 years)
•3) Fasting blood glucose=100 mg/dL and =125 mg/dL
•4) HbA1c=5.7% and =6.4%

•1) Continuous consumption of drug, oriental medicine, dietary supplement those that affect glucose metabolism within 1 month before the first visit
•2) Following diseases :
•- cardiac failure, coronary artery disease, uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg), hyperlipidemia, diabetes (fasting blood glucose =126 mg / dL), renal dysfunction (rising more than 1.5 times the upper limit of normal creatinine) Hepatic dysfunction (ALT, AST three times higher than normal upper limit), hypothyroidism, chronic gastrointestinal disorders, gastrointestinal surgery, acute and chronic inflammatory diseases, malignant tumors, Mental diseases
•3) BMI=18.5 kg/m2 or BMI=30 kg/m2
•4) Subjects who controlling body weight or subjects who have changed of body weight more than 10 percent within 6 months before the first visit
•5) high intensity exercise regularly (> 10 hours / week)
•6) Excessive smoker (= 20 cigarettes / day)
•7) Alcoholics or those who Usually drinking more than 210 g of alcohol a week (soju about 3.5 bottles/week, 3.5 cup/day)
•8) Subjects with hypersensitivity to test materials
•9) Participation in other human study within 1 month before the first visit
•10) Pregnant or lactating women
•11) Any condition that the principal investigator believes may put the subjects at undue risk

发起方

Inje University Seoul Paik Hospital