Randomized, double blind, placebo controlled clinical study to assess efficacy and safety of NRL/MW/201901 in subjects suffering from erectile dysfunction

Abstract

Sex is an integral part of a well-being. Sexual satisfaction is the most important component of the quality of life. In management of ED overall sexual potential and quality of life needs to be taken care of as a holistic approach to management. The aim of the study was to clinically validate effect of NRL/MW/201901 a polyhedral Nutraceutical product in ED. The clinical efficacy of NRL/MW/201901 in patients suffering from erectile dysfunction was evaluated by assessing Quality of Erection Questionnaire and sexual encounter profile with Intra-vaginal ejaculation latency time, serum testosterone and anthropometric analysis etc. NRL/MW/201901 was effective in increasing erection function, orgasmic function, intercourse satisfaction, overall satisfaction and sexual desire. There is marked increase in number of sexual encounters in NRL/MW/201901 treated group. Serum levels of testosterone were increased after treatment of NRL/MW/201901 than in placebo group. It was evident from the anthropometric analysis of the subjects that there was significant increase in resting metabolism and % skeletal muscle content in NRL/MW/201901 treated group. There were no evident adverse events related to drug. Thus it could be concluded that NRL/MW/201901 is safe and effective in the treatment of mild to moderate erectile dysfunction.