30 Nov 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Vedic Lifesciences has successfully completed four human studies on sexual health, for various clients from Canada and India. Research papers for two of these studies have been published in American Journal of Therapeutics and Biomed Central Complementary and Alternative Medicine. Vedic, which recently adopted a new client-CRO model called ACElerator, is setting up an audited investigators' database in Malaysia for human clinical studies on nutraceutical products.
This is Vedic's third consecutive study on male sexual health, for the same Canadian health supplement company, which provides natural solutions for various health concerns. The study was a double-blind, randomized and placebo-controlled evaluation to substantiate the product claim of increase in ejaculate volume with regular consumption of a polyherbal supplement for male sexual health. This ICH-GCP compliant multi-centric study showed a statistically significant increase in the ejaculate volume in men using the polyherbal supplement.
Dr Navneet Sonawane, manager, clinical operations, Vedic Lifesciences, said that, "This is a proud achievement for the team at Vedic as this is the first study in India to assess ‘change in ejaculate volume as a primary efficacy endpoint'. The study population included men with perceived hypospermia men who perceived their ejaculate volume to be low and seeked improvement in ejaculate volume for better sexual gratification. Such a study population has never been included in any previous nutraceutical study. Since the primary endpoint and the population included in this study have been hitherto unexplored; it makes this study a first of its kind. The study design also assessed the effect of the polyherbal supplement on sexual function and sperm characteristics."
Mr Jayesh Chaudhary, CEO, Vedic Lifesciences, commented that, "An appropriate study design and ICH-GCP compliance helps in not only establishing safety and efficacy of the investigational product but also in publishing credible data in peer reviewed journals. ICH-GCP is an international guideline to ensure integrity, credibility and ethical conduct of clinical research. Adherence to these guidelines is strongly recommended by regulatory bodies globally. At Vedic our clients have used ICH-GCP compliant data for substantiating label claims, entering into new geographies and for promotional and marketing purposes."