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

Completed

• Conditions: Mental disorder, not otherwise specified,

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

Brief Summary

A prospective interventional single center Randomised Double Blind Placebo controlled clinical study to evaluate the Efficacy and Safety of  Instavit Sweet dreams  oral spray in the  treatment of Occassional sleeplessness Total of 50 subjects Duration of the study will not exceed 37 days The primary and secondary outcome is to compare the efficacy and safety of Instavit  sweet  dreams oral spray .

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-10
• Study Completion: 2018-01-17
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• 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.
• 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.
• 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.	Baseline to End of Treatment (28 days)

Secondary Outcome Measures

Name	Time	Method
1. Incidence and Rate of adverse events	2. Changes in insomnia severity from baseline to EOT by using insomnia severity index

Trial Locations

Locations (1)

Sapthagiri Institute of Medical Science & Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Sapthagiri Institute of Medical Science & Research Centre

🇮🇳Bangalore, KARNATAKA, India

Dr Bindumathi PL

Principal investigator

9738877298

drinduraghu@gmail.com