CTRI/2017/01/007705已完成2 期
Evaluation of Efficacy and Safety of AHPL/AYCAP/0114 capsule in Patients Suffering from Erectile Dysfunction - NI
Ari Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
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
入选标准
- •1.Male subjects aged 21-50 years suffering from ED for more than 6 months.
- •2.Subjects who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit.
- •3.Subjects should be in an active stable sexual relationship for the entire duration of study
- •4.Subjects willing to participate in clinical trial and who have read understood and signed informed consent form.
排除标准
- •1.Subjects having anatomical abnormalities of the penis.
- •2.Patients that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs.
- •3.Patients having unstable angina pectoris, myocardial infarction, stroke, chronic renal and liver diseases, uncontrolled diabetes mellitus and hypertension.
- •4.Patients receiving hormonal treatment, antidepressants, antipsychotics, or any other psychoactive drugs.
- •5.Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion.
- •6.Known cases of varicocele, hydrocele, HIV/AIDS, Hepatitis C and B, Cancer and major debilitating diseases
- •7.Patients receiving corticosteroids and diuretics.
- •8.Any major disease that in investigatorâ??s opinion may interfere with male sexual health.
- •9.Known hypersensitivity to ingredients used in study drug
- •10.Subjects with significant abnormal laboratory parameters
- •11.ECG demonstrating any signs of uncontrolled arrhythmia
研究者
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