The global market for unregulated products for sexual health is estimated at about USD 3.8 billion and is expected to reach USD 6.6 billion by 2012. However there is still a dearth of scientifically proven products in this category which is crowded mostly with products backed solely by customer testimonials and sold on the internet. Another potential hit from the Exotic Naturals pipeline of research products - HeezOn – now tries to fill this market gap through a well-designed pilot study.
A 30-day study confirmed the efficacy of HeezOn (2 capsules twice daily) in improving the overall quality of Sexual life in male subjects with various sexual disorders. There was a statistically significant (p<0.05) improvement in quality of erection & overall sexual function after 30 days of use but benefits were visible within 15 days (the first follow up visit). The increase in the Serum Testosterone level over baseline was also found to be statistically significant (p< 0.05). There were no major adverse events reported during the study.
The pilot study recruited Male Subjects (n=9) with complaints of Sexual Dysfunction. Adult, sexually active male subjects aged 25 – 45 yrs were screened for Thyroid function, Serum Testosterone, Serum Prolactin and Fasting Blood Glucose levels to exclude cases with hormonal disorders & diabetes. All subjects completed the study as per protocol. Study was conducted per Good Clinical Practices using the services of a CRO who were responsible for the independent project management, analysis and reporting of the study data.
For the evaluation of sexual function, the International Index of Erectile Function (IIEF) was completed by the subjects at baseline, Day 15 & Day 30. The impact of treatment on the sexual life of the male & female partners was assessed using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) on Day 15 & Day 30 of the study. To assess the increase in ejaculatory time, the approximate time taken for ejaculation during sexual intercourse or the Intravaginal Ejaculatory Latency Time (IELT) was evaluated. The Index of Premature Ejaculation (IPE) was also used to assess the benefits of HeezOn for males with complaints of premature ejaculation. The overall score on the IPE questionnaire was significantly higher (p< 0.05) at end of treatment. IELT for patients in the study was statistically significant (p<0.05) with 1.67 ± 0.82 minutes, which increased to 1.81 ± 0.68 & 2.19 ± 0.61 respectively on Day 15 & Day 30.
Latha Chaudhary, Founder, Exotic Naturals said the company was delighted with encouraging results of HeezOn and was discussing a placebo-controlled study in a larger sample with potential collaborators in N. America. The company is promoting this research product as a Supplement as well as an ingredient to a Functional Food or Drink.
Exotic Naturals (www.exoticnatural.com) is a Mumbai, India-based firm active in the design and development of clinically tested dietary ingredients and formulas.