An Open Label, Single-Arm, Clinical Study to Evaluate Efficacy and Safety of Chewable Gummies in Healthy Adult Subjects with Sleep Deprivation.

Ikaria Wellness Pvt Ltd0 个研究点目标入组 32 人开始时间: 待定最近更新: 2023年1月9日

试验速览

暂无简介。

•1.Healthy subjects willing to follow usual wake sleep schedule during the study period.
•2.Subjects with atleast one sleep symptom and one wake symptom in past 6 months:
•A.Sleep symptom: Difficulty initiating/ maintaining sleep, Early morning awakening, Non restorative or non refreshing sleep or insomnia.
•B.Wake symptom: comprising of sleep associated day time impairment e.g. sleepiness, fatigue, mood disturbances, cognitive difficulties, social impairment or occupational impairment.
•3.Subjects with >=42 score of Sleep Quality Scale (SQS) at screening visit.

•1.Subjects having sleep schedule changes associated with shift work.
•2.Subjects on any medications or supplements known to affect sleep-wake function must not have been taken within 2 weeks prior to enrollment.
•3.Subjects with a history of sleep apnea, chronic obstructive pulmonary disease, seizures, anxiety, depression, schizophrenia, bipolar disorder, mental retardation, a cognitive disorder, disturbance in sleep due to snoring, etc.
•4.Subjects with history of drug addiction or abuse within 12 months of the study.

发起方

Ikaria Wellness Pvt Ltd