Post-marketing open label observational clinical study w.r.t local application of Yuvnam Shaurya Oil in Erectile Dysfunction

YUVNAM PRIVATE LIMITED0 个研究点目标入组 57 人开始时间: 待定最近更新: 2022年11月21日

试验速览

暂无简介。

•1.Male 18 years and above experiencing functional ED, which will be defined as the inability to achieve or maintain erection for satisfactory sexual intercourse for more than 3 months duration.
•2.All patients experiencing a 50% or greater failure rate to maintain an erection on at least 4 separate attempts over the 4-week treatment-free baseline period.
•3.The decision for â??functionalâ?? character of ED will be taken based on the following:
•a.Good nocturnal erection prior to 2 weeks
•b.One event of sexual intercourse prior to 2 weeks
•c.Good erection during masturbation or visual sex stimulation
•4.Patients willing to give written informed consent.
•5.Patients are fit and no need for any hospital administration.
•6.Agree to following instruction of doâ??s and donâ??ts in regular daily lifestyle.
•7.Patients willing to perform all study related procedures including the use of study medicine, allow the physical and other tests and willing to document symptoms and medication.

•1.Conditions that preclude study entry included anatomical abnormalities of the penis, radical prostatectomy, spinal cord injury, unstable angina pectoris and myocardial infarction.
•2.Patients will be also excluded if they had hypertension or poorly controlled diabetes mellitus with complications.
•3.Patients receiving hormonal treatment, treatment with antidepressants, antipsychotic or other psychoactive drugs, or those with serene psychiatric symptoms will also be excluded.
•4.Inability to carry out visits for the study.
•5.Chronic & acute disorders requiring hospital admission
•6.Known HIV-positive, Hepatitis B or C status.
•7.Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.

发起方

YUVNAM PRIVATE LIMITED