Health Condition 1: R37- Sexual dysfunction, unspecified
Conditions
Interventions
Intervention1: Powder: 1 Tea Spoon (Each Day) for 30 Days
Intervention2: Capsule -1: 1-1 Red PF Capsule every Morning & every Evening for 30 Days
Intervention3: Capsule -2: 1 VC Capsule every Night fo
Sponsors
DrSankalp Jain
Eligibility
Inclusion criteria
Inclusion criteria: Male subjects between 18 to 64 years of age. 2. Male subjects with stable, monogamous, heterosexual relationship for at least 6 months and expected/planned to maintain this relationship for duration of study. 3. Subjects meeting with diagnostic criteria for erectile dysfunction (as per the international index of erectile function (IIEF) score lesser than or equal to 25; as specified in Urology 1999, 54: 346-351). 4. Subjects meeting with diagnostic criteria for premature ejaculation (PE score greater than or equal to 11) as specified in article published in European Urology 2007, 52: 565-573. 5. Subject and his partner agreeing to attempt sexual intercourse 2 times/ week. 6. Subject willing to give written informed consent and willing to comply with trial protocol.
Exclusion criteria
Exclusion criteria: 1. Previous events or other conditions associated with premature ejaculation/erectile dysfunction including but not limited to spinal trauma or pelvic surgery. 2. Subjects with genital anatomical deformities including but not limited to penile deformities. 3. Subjects with erectile dysfunction or premature ejaculation due medication withdrawal. 4. Sexual dysfunction in female partner, painful intercourse, partners with decreased interest in intercourse or other forms of sexual dysfunction. 5. Subjects with major psychiatric illness or previous suicidal attempts. 6. Subjects with history of epilepsy 7. Subjects with history of stroke, myocardial infraction, heart failure, unstable angina, life-threatening arrhythmia and hypotension with in past 6 months. 8. Subjects for whom sexual activity is inadvisable because of their underlying disease status. 9. Subject is a known case of autonomic neuropathy, retinitis pigmentosa, bleeding disorders, sickle cell anemia and active peptic ulcer disease. 10. Subjects with significant and uncontrolled hematological/metabolic/ endocrinologial/respiratory/cardiovascular/neurological/psychiatric /liver/kidney diseases. 11. Subjects with resting hypotension (BP 90/50) or hypertension ( BP 170/110) Proprietary and confidential informat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of the investigational product will be Proprietary and confidential information Page 8 of 29 assessed by the Clinical AEs, including laboratory abnormalities Assessment Intervals Day 1 Day 35Timepoint: Day 1, Day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| ïâ??§ Improvement Sperm concentration per milliliter of seminal fluid ïâ??§ Improvement Proportion of Sperm motility ïâ??§ Improvement Proportion of Sperm morphology Timepoint: Day 1, Day 35 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Pvt. Ltd
Outcome results
None listed