KCT0001040已完成未知
The clinical pilot study for the evaluation of the efficacy and safety of Monascus-fermentation (Monascus-fermented black bean) on reducing body weight and serum total cholesterol obese subjects
Inje University Seoul Paik Hospital0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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 65(Year)（—）
- 性别
- All
入选标准
- •1) Male and female subjects between 20-65years of age inclusive.
- •2) BMI of 25.0-29.9kg/m2
- •3) Serum total cholesterol = 240mg/dl
- •4) Evidense of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
排除标准
- •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 who taking anti-hypercholesterolemia
- •4. Subjects with endocrinopathy or abnormal screening TSH value(=0.1uU/ml or =10 uU/ml).
- •5. Serum AST/ALT = 3 times the upper limit of normal.
- •6. Serum creatinine = 2 times the upper limit of normal.
- •7. Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon.
- •8. Subjects with clinically significant cardiovascular disease within the 6 months prior to screening.
- •9. Subjects with a history of cancer and intervention within the 5 years prior to screening.
- •10. Subjects with a history of CNS disorder(depressive disorder, schizophrenia, alcoholism, drug addiction).
- •11. Women of childbearing age who are disagreed with effective contraceptions in the clinical trial period.
- •12. Woman who are pregnant or lactating.
- •13. Participation in any clinical trial within the 3 months prior to screening.
- •14. Subjects who change weight over 10 percent within 3 months
- •15. Subjects with the musculoskeletal disorders or restricted physical activity.
- •16. Subjects who could affect preclude evaluation of response in the opinion investigator.
研究者
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