Health Condition 1: N529- Male erectile dysfunction, unspecified
Conditions
Interventions
None listed
Sponsors
YUVNAM PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Frequency of erection during sexual activity. 2.Quality of erection during sexual activity. 3.Maintenance of erection till the end of intercourse. 4.Confidence in getting and keeping erection. International Index of Erectile Functioning (IIEF) The Erection Hardness Score (EHS) Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| No incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study periodTimepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDR JAYESH THAKKAR
The Ayurveda Clinic and Research Centre
Outcome results
None listed