The clinical study for the evaluation of the efficacy and safety of Monascus-fermentation (Monascus-fermented black bean) on reducing body weight of overweight or obese subjects

Inje University Seoul Paik Hospital0 个研究点目标入组 60 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•1) Male and female subjects between 20-65years of age inclusive.
•2) BMI of 25.0-29.9kg/m2
•3) Evidense of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.

•1. Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg and also taking a beta blocker or a hydragogue.
•2. Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL.
•3. Subjects with endocrinopathy or abnormal screening TSH value(=0.1uU/ml or =10 uU/ml).
•4. Serum AST/ALT = 3 times the upper limit of normal.
•5. Serum creatinine = 2 times the upper limit of normal.
•6. Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon.
•7. Subjects with clinically significant cardiovascular disease within the 6 months prior to screening.
•8. Subjects with a history of cancer and intervention within the 5 years prior to screening.
•9. Subjects with a history of CNS disorder(depressive disorder, schizophrenia, alcoholism, drug addiction).
•10. Woman who are pregnant or lactating or women of childbearing age who are disagreed with effective contraceptions in the clinical trial period.
•11. Participation in any clinical trial within the 3 months prior to screening.
•12. Subjects who change weight over 10 percent within 3 months
•13. Subjects with the musculoskeletal disorders or restricted physical activity.
•14. Subjects who could affect preclude evaluation of response in the opinion investigator.

发起方

Inje University Seoul Paik Hospital