Evaluation of efficacy and safety of â??SHL 1047â?? in patients suffering from Primary Insomnia- A Randomized, Double Blind, Placebo Controlled, Comparative, Interventional, Multi-centric, Prospective, Clinical Study - NI

SAVESTA LIFESCIENCES INC0 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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•1) Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent
•2)Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR)
•3)Insomnia Severity Index more than 7 and less than 21
•4)Subjects willing to sign inform consent form
•5)A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period
•6)Willing to limit alcohol, caffeine, and nicotine consumption while in the study

•1)History or diagnosis of another sleep disorder
•2)Difficulty sleeping due to a medical condition
•3)History of a neurological disorder
•4)History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication
•5)On-going depression and generalized anxiety disorder (diagnosis on PHQ 9 and GAD 7 score scales)
•6)History of substance abuse or dependence
•7)History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at Pre study Visit
•8)Taking certain prohibited medications
•9)Subjects with habit of smoking Cigarette etc.
•10)Subjects with known history of hepatitis B and/ or C
•11)History of malignancy less than or equal to 5 years prior to signing informed consent
•12)Known hypersensitivity to any of the ingredients of â??SHL 1047â??
•13)Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol

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