Assessment of onset, duration, sleep efficiency and quality of sleep through SleepRiteTM combination product(s) on adult subjects with difficulties in falling asleep
Journal Title: International Journal of Medical and Health Research - Year 2019, Vol 5, Issue 1
Abstract
Background: Sleep is a basic requirement of the human body as is eating or breathing. Time and again it has been demonstrated how sleep deficiency are detrimental to general metabolism and bio-systems of the body. Sleep disorders affecting significant populations are a global phenomenon reported across both, advanced and emerging economies. Sleep inadequacy has a direct tangible impact on health and also on the quality of life. Poor sleep by research, has been consistently linked to metabolic pathologies, cognitive productivity, physical performance, cardiac and Immunological health. In this study, the objectives predominantly were to determine the safety and efficacy of SleepRiteTM combination product(s) through measures of onset, duration, sleep efficiency and quality of sleep. The active investigational product (SleepRiteTM) as a combination of chamomile, melatonin, valerian, L-tryptophan and passion flower extracts. Further to this, to analyze the effects of the combination product(s) on the mean improvement in onset, duration, sleep efficiency and quality of sleep in comparison with the placebo. Methods: The study was a randomized, single-blind (subject), two center, crossover, placebo-controlled study to evaluate safety and efficacy of SleepRiteTM (consisting of chamomile, valerian, melatonin, L-tryptophan and passion flower extracts) supplement on mean improvement in onset, duration and quality of sleep in adult literate subjects (n=24). There were two dosages of the combination product of SleepRiteTM evaluated in the study, one 66% concentration and another with 100% concentration, both in comparison with the placebo. Study was conducted through four visits over a period of about thirty days. Subjects who had received a combination product of SleepRiteTM 66% received a SleepRiteTM 100% and vice-versa. At each visit, the mean improvement in onset, duration, sleep efficiency and quality of sleep were deduced by means of subjective and objective assessments with subject diaries, Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) throughout the study. The secondary efficacy variables included assessments of study products on day-time functioning by recording ISI, PSQI scoring across the study, summarized by visits and treatments. The secondary variables of safety and tolerability were estimated by way of adverse events reporting and subject diaries. The investigational study products were consumed in several flavours and subjects’ preferences to these were also evaluated. Conclusions: Consumption of SleepRiteTM (combination of active products) has shown significant improvement of sleep in standard and subjective measures of sleep onset, latency and sleep efficiency. It has been found that there is considerable reduction in mean onset of sleep for subjects with SleepRiteTM 100% (17.25 minutes) administration as compared to SleepRiteTM 66% (22.08 minutes) when compared against Placebo arm (32.13 minutes). This clearly shows that both active strengths in SleepRiteTM study have shown substantial improvement in the onset of the sleep. There is appreciable increase in duration of sleep when subjects were under SleepRiteTM 100% (7.9 hrs) administration as compared to SleepRiteTM 66% (6.8 hrs) as compared to the Placebo arm (6.1 hrs). It has been found that there is substantial increase in sleep efficiency for subjects on SleepRiteTM 100% (by 91%) administration as compared to the SleepRiteTM 66% (by 86%) administration when compared to placebo arm (by 80%). However, there were no significant changes noted in the quality of sleep as the sample population was small and the sample size did not adequately justify the above objective. However, trends showed some positive changes were observed amongst people with SleepRiteTM in the quality of sleep.
Authors and Affiliations
Dr. Shobha N, Dr. Sampath V, Dr. Preethi Shivayogi, Dr. Jaishankar, Dr. Krathish Bopanna
Keywords
Related Articles
- EP ID EP582510
- DOI -
- Views 166
- Downloads 0
Comparision of spinal Anaesthesia vs General Anaesthesia for laparoscopic cholecystectomy: A Randomized study
Introduction: laparoscopic surgical techniques have been rapidly accepted by surgeons worldwide with published reports describing the benefits of less post-operative pain, decreased hospital stay and earlier return to wo...
Evaluation of factors determining pulmonary function in paediatric scoliosis
Scoliosis affects approximately 7 million people in the United States. Infantile scoliosis is a rare entity, amounting for less than 1% of population. Aims and Objectives: To evaluate the factors determining the pulmonar...
The screening test for angle closure glaucoma in high risk patients
Introduction: It is estimated by the year 2010, 60.5 million people would be burdened by glaucoma and that by 2020 there would be 79.6 million sufferers, 47% of the glaucomas worldwide would be in Asia with more than 75%...
Comparative evaluation of a rapid test with ELISA for the detection of dengue infection
Introduction: Dengue is a global health issue. The clinical illness ranges from an asymptomatic febrile illness to dengue haemorrhagic fever (DHF) and dengue shock syndrome (DSS). Objectives: The present study was undert...
Assessment of repair of flexor tendon in zone II, with modified kessler technique to know the functional outcomes
The management of tendon injuries has not only seen advances in primary care, repair technique, suture technique, understanding of biomechanics and postoperative evaluation protocol, but also a drastic change in mobiliza...