Health Condition 1: null- erectile dysfunction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects who have scored 22 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening. 2. Subject without any organic cause of Sexual Dysfunction. 3. Subjects should be in an active stable sexual relationship for the duration of study
Exclusion criteria
Exclusion criteria: 1. Subjects with major illnesses and sexual dysfunction due to anatomical, surgical or pharmacological causes 2. Subjects with total erectile failure or any other sexual disorder 3. Subjects with history of disorders that may cause priapism 4. Subjects with history of major psychiatric disorder 5. Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery 6. Patients with preexisting systemic disease necessitating long-term medications, genetic and endocrinal disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate efficacy of JP2016 Capsule Erectile function of penis on Erectile function subscale of IIEF Questionnaire 2.To evaluate efficacy of JP2016 Capsule on Hardness of penis on Erection Hardness ScoreTimepoint: Day -3, Day 0, Day 15 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate efficacy of JP2016 Capsule on Male sexual health on EDITS questionnaire 2.To evaluate efficacy of JP2016 Capsule by assessing Changes in serum testosterone levels 3.To evaluate efficacy of JP2016 Capsule on Global assessment for overall improvement by the investigator and by the patient at the end of the study treatment 4.To evaluate Tolerability of JP2016 Capsule 5.Adverse events 6.Laboratory parametersTimepoint: Day -3, Day 0, Day 15 and Day 30 | — |
Countries
India
Contacts
Target Institute of Medical Education and Research