Vedic Completes Third Men's Sex Health Study

REDWOOD SHORES, Calif.Vedic Lifesciences has completed a third consecutive clinical study on men's sexual health for a Canadian supplement manufacturer, to substantiate product claims for a polyherbal supplement. Two prior studies were published in peer-reviewed journals, American Journal of Therapeutics and BMC Complementary and Alternative Medicine.

In the most recent study, Vedic employed a double-blind, randomized and placebo-controlled design to investigate the effects of a multiple-herb formulation on ejaculate volume. The ICH-GCP (International Conference on Harmonization/WHO Good Clinical Practice)-compliant multicenter study found regular consumption of this herbal formula by men with perceived hypospermiathey perceived their ejaculate volume to be low and sought improvement in ejaculate volume for better sexual gratificationresulted in a statistically significant increase in the ejaculate volume.

"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," noted Navneet Sonawane, manager of clinical operations for Vedic Lifesciences. " 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."

Vedic CEO Jayesh Chaudhary highlighted the importance of appropriate study design and ICH-GCP compliance, which he said helps not only to establish safety and efficacy, but also to publish credible data in peer-reviewed journals. "ICH-GCP is an international guideline to ensure integrity, credibility and ethical conduct of clinical research," he explained. "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."