A Prospective, Randomized, Double blind, Placebo-controlled cross overstudy to evaluate the effect of Standardized Extracts of Ashwagandha(Withania Somnifera) on Transient Insomnia. - RESTWE

International Institute of Sleep Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Individuals who are willing to participate in the study and signed the informed consent will be screened for the study. The target population includes individuals residing in Mumbai and Thane, India (to facilitate logistics and investigations). In addition to we will adhere to the following inclusion criteria
•1.Individual in good health with normal hearing
•2.Individuals with normal sleep habits with PSQI scores < 5
•3. Women of child-bearing potential (WOCBP, refer to the appendix for definition) willing to use an adequate method of contraception to avoid pregnancy throughout the study period.

•Individuals with any heart-related problems such as IHD, VHD, Pacemakers.
•Those with moderate to severe sleep apnea, RLS, Narcolepsy, respiratory, and seizure disorder.
•Individuals who have traveled in time zones in the past 3 months.
•Participants who have worked in shifts in the past 4 weeks.
•Individuals with severe grade untreated depression.
•Women who are pregnant or nursing.
•Participants taking over the counter medicines, herbal medicines which are anxiolytics, CNS active drugs, antidepressants, those working on the sleep-wake cycle.
•History of drug addiction/abuse in the last 12 months.
•History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes more than 2 alcoholic drinks per day

发起方

International Institute of Sleep Sciences