Clinical validation of the potential of herbal extract blend in alleviating the stress and related conditions: A randomized, placebo-controlled, cross-over clinical study. - Nil

isarga Biotech Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•1)Participants aged greater than or equal to 30 and less than 60 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-V-TR);3)Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate;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 the study period;6)Subjects with a score of 14-26 on the Perceived Stress Scale (PSS);7)Willing to limit alcohol, caffeine, and nicotine consumption while in the study;8)Free of psychiatric conditions other than perceived stress.

•1.Difficulty sleeping due to a medical condition
•2.History of a neurological disorder
•3.History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication
•4.On-going clinical depression and anxiety disorder (showing moderate to severe diagnosis on PHQ 9 and GAD 7 scales)
•5.History of substance abuse or dependence
•6.History or current evidence of a clinically significant cardiovascular disorder at Pre study Visit
•7.Taking certain prohibited medications
•8.Consumption of more than 15 cigarettes a day
•9.History of malignancy less than or equal to 5 years prior to signing an informed consent
•10.Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.

发起方

isarga Biotech Pvt. Ltd.