Clinical Evaluation of Ashwagandha Standardized Extract (KSM 66) for itsPharmacological Actions on Sleep in Subjects Having Insomnia and HealthySubjects: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sleep Onset Latency (SOL)
研究概览
简要总结
Insomnia is a common public health problem with an estimated prevalence in both Western and Asian general populations in the range of 11-50%. Insomnia refers to unsatisfactory sleep quantity, manifesting as difficulty in falling asleep or early morning awakening, with or without poor sleep quality, manifesting as increased number of nightly awakenings or daytime sleepiness. It is classified as primary insomnia when it is not known to be due to any precipitating factor. An estimated 10-15% adults suffer from chronic primary insomnia. Primary insomnia is a sleep disorder not attributable to a medical, psychiatric, or environmental cause.
Plant derived drugs have been used since antiquity for the treatment of insomnia. Ashwagandha is commonly used in emaciation of children (when given with milk, it is the best tonic for children), debility from old age, rheumatism, vitiated conditions of vata, leucoderma, constipation, insomnia, nervous breakdown, goiter etc. (Sharma, 1999). This herb is considered an adaptogen which is a nontoxic herb that works on a nonspecific basis to normalize physiological function, working on the HPA axis and the neuroendocrine system. It is effective for insomnia but does not act as a sedative. It’s rejuvenative and nervine properties produce energy which in turn help the body to settle and sleep. Thus, it helps the body to address a stress related condition rather than masking it with sedatives. An herb that rejuvenates the nervous system, erases insomnia and eases stress. Animal and human studies have demonstrated that Ashwagandha has anti-anxiety and mood-elevating capabilities. However, clinical effects of Ashwagandha in sleep are lacking. Hence, this prospective, randomized, placebo-controlled study is being planned to evaluate the pharmacological effects of Ashwagandha Standardized Extract (KSM66) on sleep in subjects having insomnia and healthy subjects.
The aim of this study is to assess the potential of standardized extract Ashwagandha (Withania Somnifera) in treatment of Insomnia.
This work will try to identify the potential for the use of Ashwagandha standardized extract for treatment of Insomnia by assessment of the effect of Ashwagandha on sleep in healthy subjects and those with insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of insomnia based on DSM-IV criteria
- •More than 30 minutes to fall asleep and subjective total sleep time of ≤6.5 hours per night (for at least 3 nights per week); and daytime complaints associated with disturbed sleep
- •Habitual bedtime between 8.30 pm to midnight
- •Body Mass Index between 16.5 to 30 kg/sq.m.
- •Subjects able to understand the sleep diary and are able to and willing to fill the sleep log diary and follow other procedures required by the study protocol
- •Subjects who sign the informed written consent.
排除标准
- •Pregnant or breast-feeding women or women with positive urinary pregnancy test at screening.
- •Known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, haematological or neurological illnesses.
- •Presence of any current psychiatric disorders that are judged by investigator as potentially causing or contributing to insomnia.
- •Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnea.
- •Substance dependence/ abuse in the past one year or with alcohol abuse are ineligible.
- •Those using tobacco products during night awakenings.
- •History of seizures or significant head trauma.
- •Subjects who travelled across four or more time zones or worked on night or rotating shifts in previous 7 days before study initiation or who plan to do the same during the study period.
- •Currently taking any medication on a regular basis (except for antihypertensives, antidiabetics, lipid lowering agents and drugs for primary cardiovascular prophylaxis).
- •Any other investigational drug was used within three months prior the entry in this study.
- •Those who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.
结局指标
主要结局
Sleep Onset Latency (SOL)
时间窗: 6 wks.
次要结局
- 1. Total sleep time (TST) by Actigraphy(2. Wake After Sleep Onset by Actigraphy)