â??A Prospective, interventional, single center, randomised, parallel, double blind, and Placebo controlled clinical study to evaluate the efficacy & safety of InstavitÂ® Sweet Dreams oral spray in the treatment of occasional sleeplessness.

Instavit Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Subjects who works in shifts and who travels regularly facing problems of jetlag and occasional sleeplessness.
•2. Subjects Meet Criteria for Insomnia Disorder as per Epworth sleepiness scale.
•3. Subjects who scores less than 21 of Insomnia Severity Index.
•4. Mentally, physically and legally eligible to give informed consent.
•5. Subjects willing and able to provide informed consent voluntarily
•6. Subject is willing and able to comply with all trial requirements

•1. Significant medical or psychiatric illness
•2. Diagnosed or occult sleep disorders (evident on screening polysomnography) other than Primary Insomnia
•3. Subjects with high severity of Insomnia scoring more than 21 of Insomnia Severity Index.
•4. Hearing or memory impairments
•5. Subjects having history of drug or alcohol abuse
•6. Previous receipt of Study Drug
•7. History of HIV, HAV, HBs Ag
•8. Volunteers who have participated in any drug research study within past 3 months.
•9. Presence or history of hypersensitivity to any of the active or inactive ingredients
•10. Pregnant or lactating women

发起方

Instavit Ltd