A triple blind, randomized, double dummy, prospective placebo controlled dose determination study to investigate the safety and efficacy of E-MA-H and E-MA-HP capsules as a dietary supplement for Male Sexual Health.

Triple blind, randomized, double dummy, prospective placebo controlled, dose determination study to investigate the safety and efficacy of E-MA-H and E-MA-HP capsules as dietary supplements for Male Sexual Health. About 156 males with Male Sexual Dysfunction (MSD) between 21-60 years of age will be enrolled in the study to get 120 completed subjects. Recruitment of subjects will be done through the investigator?s own direct contact or subject referral to the selected investigators.For each subject, the study will terminate after a maximal period of 60 days from day 1. On Screening Visit (Visit I), a thorough explanation will be given to each patient on the aims and course of the study, as well as a full explanation on dosage, mode of administration, safety and efficacy of E-MA-H and E-MA-HP Capsules. After reading and signing an informed consent, Investigator/co-ordinator will administer each question from IIEF (International Index of Erectile Function)) and IPE (Index of Premature Ejaculation) questionnaires to the subject and response from the subject will be noted down. If subject is fulfilling the inclusion criteria with respect to IIEF and IPE scores then he will be sent for ECG, Blood & Urine examinations. If the subject satisfies the inclusion criteria, he will be randomized in the study. There will be 7 days period between screening and baseline visit which could be extended maximum up to 15 days, depending upon the medication the subject may be on at the time of screening. Subject will be asked to stop any medication that he might be taking for MSD. He will be put on 15 days wash-out period if he is taking Ayurvedic/Herbal medicine and on 7 days wash-out period if he is taking any other treatment for MSD. In case the investigations are not done in the preset time period & the record of the same will be maintained At baseline Day 1, physical examination will be performed. IIEF, IPE questionnaires will be filled. Intravaginal Ejaculatory Latency Time (IELT) will be also noted down in minutes. First follow-up visit will be after 7 days. The subsequent follow up visits will be at Day 15, Day 30, Day 45, and Day 60. For each visit subject will be provided with new IIEF (full version), IPE questionnaires. IELT will be also noted down in minutes. Each subject will receive another supply of the trial medications during these visits except at day 7 and day 60. On Day 30 and Day 60 EDITS questionnaire subject and partner version will be also taken.