A clinical study to compare the efficay and safety of Instavit oral spray for the Occassional Sleeplessness

Not Applicable

Completed

• Conditions: Health Condition 1: F99- Mental disorder, not otherwise specified

• Registration Number: CTRI/2017/09/009834
• Lead Sponsor: Instavit Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-01-17
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Improvement in overall condition by assessing the changes in sleep quality using sleep logs and sleep dairy from baseline to EOT.Timepoint: Baseline to End of Treatment (28 days)

Secondary Outcome Measures

Name	Time	Method
1. Incidence and Rate of adverse events <br/ ><br>2. Changes in insomnia severity from baseline to EOT by using insomnia severity index <br/ ><br>3. Assessment of sleep quality by using Pittsburgh insomnia rating scale <br/ ><br>Timepoint: Baseline to End of Treatment (28 days)