A study of Chewable Gummies for Sleep Deprivation.

Not Applicable

Completed

• Registration Number: CTRI/2022/08/044862
• Lead Sponsor: Ikaria Wellness Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-30
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes in Sleep Quality Scale (SQS)Timepoint: baseline i.e., Day 01 and after treatment on Day 15 (plus minus 2 days) and Day 25 (plus minus 2 days).