KCT0004286尚未招募未知
Efficacy and safety of HT080 on prostate gland health: a 12-week, randomized, double-blind, placebo-controlled clinical trial.
EUMED0 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
- 尚未招募
- 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 aged 40 to 75 years
- •2) International Prostate Symptom Score of 8 to 19
- •3) Prostate size of = 20 g
- •4) Participants who agree to participate and sign the informed consent
排除标准
- •1) Currently being treated for clinically relevant acute or chronic cerebrovascular, immune, respiratory, hepatobiliary, kidney and urinary, neurological, musculoskeletal, mental, infectious, or hemato-oncological diseases (However, it is possible to participate in the trial at the investigator’s discretion considering the condition of the participants)
- •2) Serum PSA level = 10 ng/ml (However, those whose test results are had not been confirmed as cancer within 6 months can be enrolled)
- •3) Maximal urinary flow rate (Qmax) less than 5 mL/sec
- •4) Post-void residual urine volume (PVR) greater than 200 mL
- •5) Bladder tumor, urinary stone, urethral stricture, bladder neck contracture, inflammation of the lower urinary tract (bladder and urethra), or urinary tuberculosis
- •6) Diagnosed as prostate cancer
- •7) History of genitourinary surgery including prostate surgery or other invasive procedures for prostate treatment (trans-urethral needle ablation, laser treatment, etc.)
- •8) Uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg measured after a 10-min rest)
- •9) Uncontrolled diabetes (fasting blood sugar level = 180 mg/dL or those who have started to take drugs because of diabetes within 3 months)
- •10) Thyroid diseases
- •11) Creatinine level = 2 times the upper limit of normal
- •12) Aspartate and alanine aminotransferase levels = 3 times the upper limit of normal
- •13) Received drugs for BPH (antimuscarinics, etc.) or functional foods within 4 weeks
- •14) Participation in other clinical trials within 3 months or plan to participate in other trials during this study
- •15) Participants who are deemed unsuitable at the investigator’s discretion
研究者
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