Health Condition 1: null- Male Sexual Health
Conditions
Interventions
Intervention1: E-MA-H &
E-MA-HP: 2 capsules twice a day with milk for 2 months
Control Intervention1: Placebo (Starch): 2 capsules twice a day for 2 months
Sponsors
Exotic Naturals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males aged between 21-60 yrs 2. Subject having a monogamous, heterosexual relationship 3. Subject satisfying any one of the following criteria. a. Subject having Erectile dysfunction IIEF A Score in between 11-21 b. Premature Ejaculation IPE Score in between 18-28 c. Other sexual dysfunction IIEF B Score in between 21-30
Exclusion criteria
Exclusion criteria: 1. Subjects taking herbal or Ayurvedic/Herbal treatment in the last 15 days (Only for Male Sexual Dysfunction). 2. Subjects taking any other treatment in the last 7 days (Only for Male Sexual Dysfunction). 3. Subjects with major psychiatric disorders or severe systemic disorders 4. History of stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia or spinal cord injury within the past 6 months. 5. Subject having uncontrolled diabetes mellitus and/or h/o diabetes mellitus for more than 10 years. 6. H/o Male Sexual Dysfunction more than six months in diabetic subjects. 7. Anatomical deformity of the penis such as severe penile fibrosis or Peyronie's disease or phimosis. 8. K/C/O HIV Positive and AIDS 9. Has an abnormal thyroid stimulating hormone (TSH) level lower than 30% of LLN or more than 30% of ULN. 10. Has erectile dysfunction caused by neurological or endocrine factors such as hyperprolactinemia or low serum testosterone levels (<200 ng/dl). 11. Has a history of drug abuse (alcohol, marijuana, cocaine, or opiates). 12. Is using medications that are known to cause sexual dysfunction (cimetidine, spironolactone, thiazides, adrenergic blockers, anti- depressants etc). 13. Subject has participated in any clinical trial within last 30 days. 14. Subjects not ready to sign the consent & unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) International Index for Erectile function(subscale A) 2) International Index for Erectile function(subscale B) 3)Index for Premature EjaculationTimepoint: Screening (D-7/-15), Day 1, Day 7, Day 15, Day 30, Day 45 & Day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Total score of International Index for Erectile function (scoreA + scoreB) 2) Serum Testosterone 3) Erectile dysfunction inventory for treatment satisfaction questionnaire (male & female version). 4) Global assessment by the investigator.Timepoint: 1) Screening (Day-7/Day-15), Day 1, Day 7, Day 15, Day 30, Day 45 & Day 60. 2) Screening (Day-7/Day-15), Day 30 & Day 60. 3) Day 30 & Day 60. 4) Day 60. | — |
Countries
India
Contacts
Public ContactDr. Mugdha Kulkarni
Outcome results
None listed