None listed
Conditions
Interventions
Intervention1: Paternia tablets: One tablet twice daily
Intervention2: Paternia tablets: Two tablets twice daily
Control Intervention1: Placebo: Two tablets twice daily
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 21 to 50 years 2. Sperm count ? < 50 million/cu mm 3. Sperm motility < 50 % (according to World Health Organization [WHO] 1999 criteria) 4. Normal Sperm morphology < 50 % 5. No history of taking therapy for infertility 6. No history of obstructive azoospermia 7. Normal female partner 8. Willing to sign Informed consent 9. Subjects likely to be available for all visits during follow-up period
Exclusion criteria
Exclusion criteria: 1. Any organic cause for male factor infertility 2. Prostato-vesiculo-epididymitis 3. Not planning for IVF etc in the proposed study period 4. Abnormal hormonal profile: gonadotropins, T, E 2, and PRL, FSH>15 5. Presence of antispermatozoa antibodies 6. Severe oligospermia 7. Varicocoele 8. Azoospermia 9. Presence of infectious genital diseases 10. Seminal white blood cells (WBCs) more than 1 x 10 6/mL 11. Major hepatic and Renal disease 12. Myopathy 13. Primary testicular diseaease 14. Subject with history of allergy to any ingredient of the formulation 15. Subject not likely to be available for follow-up. 16. Participation in another clinical trial in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in sperm count, motility, morphology, motility index, teratozoospermia index (TZI), Fertilization potential by HOS testTimepoint: Day 0, 90, 180, 270 & 360 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy RateTimepoint: Day 0, 30, 60, 90, 180, 270 & 360 | — |
Countries
India
Contacts
Public ContactDr. P.M. Gopinath
Outcome results
None listed