Evaluation of efficacy and safety of EL STI 01 in healthy individuals having stress and insomnia- A Randomized, Double blind, Placebo controlled, Multi-centric, Interventional, Prospective, Clinical Study - NI

Emil Pharmaceutical Industries Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1. Healthy Participants who perceive themselves to be under stress and having a score between 14 -24 on the Perceived Stress Scale (PSS)
•2. Healthy Participants having insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-5)
•3.Insomnia Severity Index more than 7 and greater than 21
•4. Participants 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

•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
•6.History of substance abuse or dependence
•7. Taking certain prohibited medications [opium, cannabis (marijuana) and methamphetamines]
•8.Participants with habit of smoking Cigarette etc.
•9.Participants with known history of hepatitis B and or C, diabetes mellitus, hypertension, cancer
•10.History of malignancy less than or equal to 5 years prior to signing informed consent
•11.Known hypersensitivity to any of the ingredients of study products
•12.Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his or her participation in, and completion of the protocol

发起方

Emil Pharmaceutical Industries Private Limited