KCT0005912招募中未知
Efficacy and Safety of ABF on Blood Flow Improvement; A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
JBKLAB0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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
- 25(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1. Adult men and women who aged 25 to 70
- •2. Those who meet at least three items under the following conditions(Screening visit)
- •1) A person with 200 to 239 mg/dL of Total Cholesterol on empty stomach
- •2) A person with 130 to 159 mg/dL of LDL-Cholesterol on empty stomach
- •3) A person with 100 to 125 mg/dL of Blood sugar on empty stomach
- •4) A person with 120 to 139 mmHg of Systolic blood pressure
- •5) A person whose BMI is not less than 25 kg/? and not more than 30 kg/?
- •6) Persons with waist/hip circumference (WHR) greater than 0.9 for males and 0.85 for females
- •3. A person who consented to participate in this clinical trial and signed a Informed consent form before the trail began.
排除标准
- •1. Those who are currently being treated with severe cardiovascular, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal system, mental, infectious disease, and malignant tumor (However, in the case of subjects who are clinically stable, considering subject's condition, can participate in the clinical trial at the discretion of the tester.)
- •2. Those who have used Anticoagulants (warfarin, etc.), antiplatelet agents (aspirin, clopidogrel, etc.), calcium antagonists, beta-blockers, hormone agents (oral and injection drugs such as dexamethasone, betamethasone, somatropine, lutropine alpha), diabetes medication (oral and injection drugs) within 2 weeks of screening visit
- •3. Those who have consumed health functional foods that may affect blood flow such as red ginseng, ginseng, natto, guava leaf extract, indigestible maltodextrin, etc. within 2 weeks of screening visit
- •4. Uncontrolled hypertension persons (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measurement criteria after 10 minutes of stability in human subjects)
- •5. Uncontrolled diabetic persons (fasting blood sugar of 180 mg/dL or higher)
- •6. Those whose TSH is not more than 0.1 µIU/mL or greater than 10 µIU/mL
- •7. Those whose Creatinine is more than twice the normal upper limit of the study institution
- •8. Those whose AST(GOT) or ALT(GPT) is more than 3 times the normal upper limit of the study institution
- •9. Those who have operation history within 3 months of screening visit
- •10. Those who have been medicated hyperlipidemia drug newly within 3 months of screening visit
- •11. Those who complains of severe gastrointestinal symptoms, such as heartburn or indigestion
- •12. Persons who are sensitive to or allergic to investigational product ingredients for this clinical trial
- •13. Persons who are pregnant or who are lactating women or who have a plan to conceive during this clinical trial period
- •14. Those who participated in other clinical trials within 3 months of screening visit, or who plan to participate in other clinical trials after the start of this clinical trial
- •15. A person who determines that the Investigator is inappropriate for clinical trials
研究者
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