KCT0008306已完成Unknown
Efficacy and safety of Rubus occidentalis on andropause symptoms; A 12 weeks, randomized, double-blind, placebo-controlled exploratory clinical trial
Berry&Bio Food Research Institue0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 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
入排标准
- 年龄范围
- 40(Year) 至 75(Year)（—）
- 性别
- Male
入选标准
- •1. Men aged between the 40 and 75 years
- •2. Andropause symptoms
- •? AMS survey result of 27 points or more
- •? As a result of the ADAM survey, if question 1 or 7 is yes” or 3 or more of the other questions are yes”
- •3. Those with TT (Total Testosterone) 2.51 ng/ml or more and 10.63 ng/ml or less
- •4. After listening to the detailed explanation of this clinical trial and fully understanding, a person who consented to participate in this clinical trial and signed a informed consent
排除标准
- •1. Those who have received testosterone or testosterone inhibitors within 2 months
- •2. Those who received intramuscular testosterone within 6 months
- •3. BMI (Body Mass Index) 30 kg/m2 or more
- •4. T-PSA (Total Prostate Specific Antigen) 4.0 ng/ml or more
- •5. hyperprolactinemia (blood prolactin is 3 times or more of the upper limit of the reference range)
- •6. Severe acute or chronic cardio-cerebrovascular disease, metabolic disease, liver and biliary tract disease, pancreatic disease, muscle disease, neurological disease, mental disease, endocrine system disease, immune disease, kidney disease, malignant tumor, lung disease, urinary system diseases, and other diseases
- •7. Diagnosed with diabetes or those with an HbA1c of 6.5% or more
- •8. Those with hypotension below 90/50 mmHg or uncontrolled hypertension above 160/100 mmHg
- •9. A person who has taken medication or used treatment to improve and treat male menopause, sexual function, impotence, enlarged prostate, etc. within 2 months
- •10. A person who has taken health functional foods and herbal medicines to improve male menopause, sexual function, impotence, enlarged prostate, etc. within 2 weeks
- •11. Those who have a history of hypersensitivity or clinically significant hypersensitivity to components of drugs and products for human application
- •12. Those with a history of gastrointestinal diseases (e.g., Crohn's disease, etc.) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of products for clinical trial
- •13. Those with a history of alcoholism or substance abuse
- •14. Those who have been diagnosed with antipsychotics or who have received drug treatment within 2 months
- •15. Those who participated in other clinical trials within 2 months
- •16. Lab test
- •- AST, ALT > 3 times or more of the upper limit of the reference range
- •- Serum creatinine > 2.0 mg/dl
- •17. A person who determines that the investigator is inappropriate for clinical trial
研究者
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