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.

Keywords:

• Alpinia galangal
• Alertness
• Caffeine
• Energy
• Daytime sleepiness
• Attentiveness
• Randomized
• Double Blind

Acknowledgments

The authors would like to thank the study participants for their effort and time, we humbly acknowledge their contribution. We would also like to thank Mr Ankul Suresh Kokate for his substantial involvement in manuscript preparation.

Disclosure statement

Dr. Shalini Srivastava and Mr. Jayesh A Chaudhary are affiliated to Enovate Biolife and Vedic Lifesciences. The authors report no other conflicts of interest in this work.

Author contribution

SS conceptualized the study design, which was reviewed by JC. The manuscript was prepared under SS supervision which was reviewed by MM and JC. All authors read and approved the final draft of manuscript.