Manisha Mishra, Nayan Patel, Maheshvari Patel

A CLINICAL INVESTIGATION ON THE SAFETY AND EFFECTIVENESS OF A NATURAL SLEEP SUPPLEMENT IN TREATING SLEEP DEPRIVATION IN HEALTHY ADULT HUMAN SUBJECTS: A STUDY ON SLEEP DISORDER MANAGEMENT

  • General Medicine
  • General Earth and Planetary Sciences
  • General Environmental Science
  • General Medicine
  • Ocean Engineering
  • General Medicine
  • General Medicine
  • General Medicine
  • General Medicine
  • General Earth and Planetary Sciences
  • General Environmental Science
  • General Medicine
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Background: Sleep disorders afflict millions globally, affecting overall health. Insomnia, characterized by difficulty falling or staying asleep, is particularly prevalent. Conventional treatments often pose side effects, prompting exploration of alternative approaches. This study investigates the safety and effectiveness of a natural sleep supplement containing Tagar (Valeriana officinalis), a key Ayurvedic herb, in addressing sleep disorders. Duri Methods: ng a 30-day study period, a cohort of 32 subjects presenting complaints regarding sleep, with a mean age of 39.63±8.37years, were treated and evaluated. The improvement in sleep quality was evaluated using Leeds Sleep Evaluation Questionnaires (LSEQ) and 'sleep diaries' that were provided to the subjects to record their sleeping patterns. Additional relevant endpoints were determined through clinical examinations, blood reports, and hedonic questionnaires for consumer feedback perception. Ethical approval was obtained prior to the commencement of the study, ensuring compliance with established research ethics. The statistical analysis of the acquired data was performed using R software (Version: 4.2.2). Results: A significant improvement in the sleep quality of subjects was observed, wherein 100% of the subjects reported facilitation in the onset of sleep, along with fewer nocturnal wakeful periods by Day 15. The ease to fall asleep exhibited a substantial increase of 258.8±76.67% (p-value<0.001), with time period to fall asleep reducing by 237.50±71.84% (p-value<0.001) after 15 days of treatment. Similarly, statistically highly significant improvements with p-value<0.001, were observed in parameters such as the time taken to awaken, the ease of waking up, a heightened sense of freshness and alertness, and diminished disruptions in balance and coordination during the morning hours. The study also identified a sixfold reduction in sleep onset latency, and a 1.3-fold increase in the overall duration of sleep. Importantly, over the course of the 30-day study period, no adverse effects or instances of treatment habituation were observed among the study subjects. The natural sleep supplement demonstrated efficacy in enhancing Conclusions: sleep quality, duration, sleep onset latency, and waking-up, while mitigating symptoms of morning fatigue. Notably, no habituation of the therapy or adverse events were observed after 30 days of regular administration. The tested treatment, 'Zzowin' tablet can be considered well-tolerated and efficacious in treating people suffering from sleep deprivation.

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