Journal of the American College of Nutrition ( IF 3.571 ) Pub Date : 2020-05-15 , DOI: 10.1080/07315724.2020.1753129 Shalini Srivastava 1 , Mark Mennemeier 2 , Jayesh Anand Chaudhary 3
- Department of Clinical development, Enovate Biolife, Mumbai, Maharashtra, India.
- Neurobiology and Developmental Sciences, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
- Vedic Lifesciences, Mumbai, Maharashtra, India.
目标：本随机、安慰剂对照研究旨在评估 EnXtra ®在健康个体中的长期安全性和可感知的精神敏锐度益处。
方法：研究参与者在12 周内服用 EnXtra ®有或无咖啡因。通过评估 QT 间期、血压和心率的变化来评估心血管安全性。此外，评估的其他功效变量是通过 Bond 和 Lader 情绪量表感知的警觉性和平静度的变化、匹兹堡睡眠质量指数的睡眠障碍和 Epworth 嗜睡量表的白天嗜睡。
结果：与基线相比，所有研究组的 ECG 或血液动力学参数均未显示任何显着变化（p > 0.05）。与安慰剂相比，EnXtra ®和 EnXtra ®加咖啡因组的消费后、警觉性和镇静评分显着增加（p < 0.001）。EnXtra ®组的日间睡眠评分下降，但变化并不显着。所有三个组的睡眠质量都没有受到干扰。
结论：研究结果证明了 EnXtra ®的精神兴奋剂功效，长期使用没有安全问题。
A Randomized Placebo Controlled Clinical Trial Demonstrating Safety & Efficacy of EnXtra® in Healthy Adults
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.