KCT0004316招募中未知
Efficacy and Safety of PSE on prostate gland health; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial
Chung-Ang Univerisity Hospital0 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
- 40(Year) 至 75(Year)（—）
- 性别
- Male
入选标准
- •1) Men over 40 and under 75
- •2) A person whose IPSS (International Prostate Symptom Score) is in the range of 8 ~ 19
- •3) A person who agrees to participate in this human body test and writes informed consent before the human body test begins.
排除标准
- •1) Those who are currently being treated for clinically significant acute or chronic cardiocerebrovascular system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal disorders, mental, infectious and blood and tumor diseases Considering the condition of the subject, the tester can participate in the test, and a simple urinary tract infection can participate after 2 weeks of treatment).
- •2) Person whose maximum urination rate is less than 5 ml / sec
- •3) Those whose residual urine content is more than 150ml
- •4) Those who have undergone genitourinary surgery, including prostate surgery, or other invasive procedures for the treatment of the prostate gland (urethral acupuncture surgery, prostate laser treatment, etc.)
- •5) Prostate volume 40g or more
- •6) Those who have been diagnosed with prostate cancer
- •7) Patients with uncontrolled hypertension (more than 160 / 100mmHg, measurement standard after 10 minutes of test subject stability)
- •8) Uncontrolled diabetic patients (fasting blood glucose above 180 mg / dl or within 3 months of starting or changing medications due to diabetes)
- •9) those with thyroid disease
- •10) Creatinine is more than twice the normal upper limit of the test laboratory
- •11) Person whose AST (GOT) or ALT (GPT) is 3 times higher than normal upper limit
- •12) Those who have taken prostatic hypertrophy drugs and dietary supplements within 4 weeks of the start of the test
- •13) Participants in other clinical trials within 3 months prior to this human trial or plan to participate in other clinical trials during this human trial.
- •14) Those who are sensitive or allergic to peanut-related foods
- •15) A person who cannot perform ultrasound examination due to anal disease
- •16) A person who judges that it is inappropriate for this human application test
研究者
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