A Randomized Placebo Controlled Clinical Trial Demonstrating Safety & Efficacy of EnXtra® in Healthy Adults.

Abstract

Objective: The present randomized, placebo-controlled study aimed to assess the long-term safety and perceivable mental acuity benefits of EnXtra^® in healthy individuals.Methods: Study participants were administered EnXtra^® with or without caffeine for a period of 12 weeks. The cardiovascular safety was evaluated by assessing change in QT interval, blood pressure and heart rate. Further, other efficacy variables evaluated were change in perceived alertness and calmness by Bond and Lader mood scales, Sleep disturbance by Pittsburgh sleep quality Index and daytime sleepiness by Epworth sleepiness scale.Results: None of the study group showed any significant change in the ECG or haemodynamic parameters as compared to baseline (p > 0.05). Post consumption, alertness and calmness scores were significantly increased in the EnXtra^®, and EnXtra^® plus caffeine group (p < 0.001) as compared to placebo. Daytime sleep scores decreased in the EnXtra^® group however change was not significant. Sleep quality remained undisturbed in all three arms.Conclusion: The findings demonstrated the psychostimulant efficacy of EnXtra^® with no safety concerns on long-term usage.