Exotic Naturals, a dietary supplements development company located in Mumbai, India is initiating a double blind placebo controlled dose determination clinical study for E-MA-H and E-MA-HP, two variants of a proprietary formula which is intended to perform as a sex stimulant (supported by an earlier pilot study). E-MA-H and E-MA-HP are non-hormonal and 100% natural supplements that address all aspects of Male Sexual Function: Libido, Erection, Ejaculation, Orgasm and Satisfaction. The product under the codename E-MA-H is being promoted in various markets currently under the brand name HeezOn, and will be launched in late 2009.
In an earlier exploratory study E-MA-H was found to increase sexual desire of the male subjects and show improvemented in maintaining healthy erectile function.
The study has received IRB approval and will be conducted under ICH-GCP guidelines in 120 subjects in the Mumbai-Pune region. For evaluation, the efficacy variables selected are IIEF (International Index of Erectile Function), EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction -subject & partner version), IPE (Index of Premature Ejaculation), IELT (Intravaginal Ejaculatory Latency Time), Testosterone and Onset of action. This is one of the largest and most organized studies of dietary supplements in the male sexual health segment planned to date. A leading Natural Products CRO Vedic Lifesciences is managing the study. The expected completion time is November, 2009.
Mr. Jayesh Chaudhary, CEO, has confirmed a collaboration agreement for co-development of the product with a Canadian Investor group who have recently entered into the Natural Products business. Other categories being developed under this partnership include joint health and sleep.
