Objective

Non-restorative sleep (NRS) affects 10% people worldwide, leading to poor sleep quality, as well as physical and cognitive fatigue. This is the first human study in which an extract of ashwagandha (Withania somnifera Dunal L.) was evaluated for effects in improving overall sleep quality in subjects with NRS.

Methods

In this randomized, double-blind, placebo-controlled trial, 150 healthy subjects scoring high on non-restorative sleep measures were given 120 mg of standardized ashwagandha extract (Shoden®) once daily for six weeks. Subjects were evaluated using the Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale. Sleep actigraphy was used to measure the onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset. Safety of the treatment was determined by testing of vitals, hematology, biochemistry and urinalysis.

Results

A total of 144 subjects completed the study, with no dropouts due to adverse events. A 72% increase in self-reported sleep quality was found for the treatment group, compared with 29% in the placebo group (p < 0.001). Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks. In the ashwagandha group quality of life (QOL) scores showed significant improvement in physical (p < 0.001), psychological (p < 0.001), and environment domains (p < 0.01).

Conclusions

Supplementation with the standardized ashwagandha extract for six weeks improved the overall quality of sleep by significantly improving the NRS condition in healthy subjects. No treatment related adverse events were reported in the study.

Trial registration

Clinical Trials Registry-India (www.ctri.nic.in). Registration number: CTRI/2017/02/007801.

中文翻译：

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一项随机，双盲，安慰剂对照研究，评估了ashwagandha（Withania somnifera）提取物对健康成年人睡眠质量的影响。

目的

非恢复性睡眠（NRS）影响全世界10％的人，导致睡眠质量差以及身体和认知疲劳。这是第一项人类研究，其中评估了南非醉茄提取物（Withania somnifera Dunal L.）对改善NRS患者总体睡眠质量的作用。

方法

在这项随机，双盲，安慰剂对照试验中，对150名在非恢复性睡眠措施上得分高的健康受试者，每天一次给予120 mg的标准ashwagandha提取物（Shoden®），持续六周。使用每周一次的“恢复性睡眠调查表”和世界卫生组织的生活质量Bref（WHOQOL）量表对受试者进行评估。睡眠记录仪用于测量睡眠潜伏期，睡眠效率，总睡眠时间和睡眠发作后的觉醒。治疗的安全性通过测试生命力，血液学，生物化学和尿液分析来确定。

结果

共有144位受试者完成了研究，没有因不良事件而退学。治疗组自我报告的睡眠质量提高了72％，而安慰剂组为29％（p  <0.001）。根据活动监测数据，治疗组的睡眠效率（SE）（p  <0.01），总睡眠时间（p  <0.001）和睡眠潜伏期（p  <0.01）和入睡后唤醒（WASO）（p  <0.05）与六周后的安慰剂对比。在ashwagandha组，生活质量（QOL）得分显示身体（p  <0.001），心理（p  <0.001）和环境（p <0.01）。

结论

补充标准的非洲醉茄提取物六周可以显着改善健康受试者的NRS状况，从而改善整体睡眠质量。研究中未报告与治疗相关的不良事件。

试用注册

印度临床试验注册处（www.ctri.nic.in）。注册号：CTRI / 2017/02/007801。