KCT0009341已完成未知
The effects of KGC08EA on efficacy and safety to improve in Andropause symptoms : A 8-week, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 96
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
- 40(Year) 至 o Limit（—）
- 性别
- Male
入选标准
- •1) Men over 40 years of age
- •2) Subjects with a total testosterone value of less than 3.5 ng/mL or male menopausal symptom survey (AMS) score of 27 or higher
- •3) Subjects who has signed the consent form after being briefed on this study
排除标准
- •1) For the purpose of treating symptoms related to men's menopause, people who have taken phosphodiesterase-5 inhibitors, androgen agent, testosterone replacement therapy, statins, fibrates, niacin, steroids, fish oil, anti-obesity treatment, ezetimibe, omega-3 fatty acids, bile acid sequesters, fiber-based laxatives phytosterol margarines, and erectile dysfunction treatments
- •2) People who has taken diuretics, beta blockers, anticoagulants, or antiplatelet drugs
- •3) People with a history of hypertension, coronary artery disease, myocardial infarction, angina, heart failure, ischemic heart disease, arrhythmia, cerebral infarction, cerebral hemorrhage, stroke, diabetes, or thyroid disease
- •4) People with psychogenic menopausal disorder
- •5) People whose liver function test (AST, ALT, Total bilirubin, Alkaline Phosphatase) value is 2.5 times higher than the normal value
- •6) People who has a history of renal failure or has a renal function test (creatinine) that is more than 30% higher than the normal value
- •7) People with prostate specific antigen (PSA) = 4.0 ng/mL
- •8) People with Hepatitis B Test Positive
- •9) People with body mass index (BMI) = 35 kg/m2
- •10) People with a history of alcoholism or substance abuse
- •11) People with a history of cancer
- •12) People who has a hypersensitivity to test products
- •13) People who is at risk of serious drug interaction due to a concomitant drug
- •14) People who is medically and mentally prohibited from taking investigation drugs
- •15) People who is legally unable to participate in clinical trials
- •16) People who participates in another study within six months before the study
- •17) People who is likely to have an uncooperative attitude in this study or a person who is judged by the researcher to be unable to proceed with the study
研究者
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