Health Condition 1: null- Erectile Dysfunction
Conditions
Interventions
Intervention1: ProSolution Pills: 1 Tablet thrice daily for 84 days
Control Intervention1: Placebo: 1 Tablet thrice daily for 84 days
Sponsors
Leading Edge Marketing, PO Box CR-56766, Suite 1210
Nassau Bahamas
Vedic Lifesciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Males aged 25-50 years, involved in a stable heterosexual relationship of >6 months Subjects with Erectile Dysfunction (ED) since at least 3 months IIEF-A (Erectile Function) score in the range of 11 ? 23 IIEF-B score (Other than Erectile Function) in the range of 21 - 35
Exclusion criteria
Exclusion criteria: Significant cardiovascular or any other co-morbidities Use of sildenafil or any other phosphodiesterase type inhibitor within previous 6 weeks Current use of any other therapy for treatment of ED Subjects with Diabetes Subjects with Hypertension Subjects taking medications known to cause ED Subjects with major psychiatric disorders Subjects with Low Testosterone Levels (<200 ng/dl) Subjects with history of spinal cord injury or a radical prostatectomy or radical pelvic surgery. Subjects with anatomical deformity of the penis which has a severe effect on sexual functioning Subjects with HIV or AIDS or any other sexually transmitted disease Subjects with Hyperprolactinemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Index for Erectile FunctionTimepoint: Screening Visit (i.e. on Day -3), Day 28, Day 56 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) EDITS Patient and Partner Questionnaire 2) Serum Testosterone Levels 3) Erection hardness score (EHS) 4) Global Assessment by the Investigator Timepoint: 1) Day 84 2) Screening Visit and Day 84 3) Screening Visit, Day 28, Day 56 and Day 84 4) Day 84 | — |
Countries
India
Contacts
Public ContactSeema Damakale
Vedic Lifesciences Pvt. Ltd.
Outcome results
None listed