Evaluation of efficacy & Safety of NST/ST/01 in healthy participants with insomnia- An Open Label, Single arm, Non- comparative, Interventional, Prospective, Clinical Study - NI

SciTech Specialties Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

暂无简介。

•1. Participants having average (average of three-night readings before baseline visit) sleep initiation greater than or equal to 30 minutes and effective sleep duration of less than or equal to 6 hours on Ballistocardiography
•2. Participants diagnosed with insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM V TR)
•3. Insomnia Severity Index score more than 7 and less than or equal to 21
•4. Participants willing to sign inform consent form and ready to follow the study protocol requirements
•5. Female participants with reproductive potential with a negative pregnancy test (Urine) and agree to use contraception throughout study period
•6. Participants willing to stop alcohol, caffeine, and nicotine consumption while in the study

•1. Participants with history or diagnosis of secondary sleep disorder (any other underlying medical or surgical condition diagnosed on the basis of history and clinical examination by the investigator)
•2.Participants with history of any neurological disorder causing interference in sleep
•3.Participants with history of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication
•4.Participants with on going depression and generalized anxiety disorder treatment
•5.Participants with history of substance abuse or dependence for the last 5 years
•6.Participants taking certain prohibited medications like opium, cannabis (marijuana) and methamphetamines etc.
•7.Participants with habit of smoking Cigarette etc. (More than 5 cigarettes per day)
•8.Participants with known history of hepatitis B and or C
•9.Participants with history of malignancy less than or equal to 5 years prior to study participation
•10.Participants with known hypersensitivity to any of the ingredients of study products
•11.Participants with 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

SciTech Specialties Pvt. Ltd.