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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009834
Enrollment
50
Registered
2017-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Instavit® Sweet Dreams 7ml/0.24 Fl OZ Sleep Aid Supplement with Melatonin & Chamomile : Spray 1-2 times into your mouth 30 minutes before sleep for 28 days Control Intervention1: Plac

Sponsors

Instavit Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Incidence and Rate of adverse events 2. Changes in insomnia severity from baseline to EOT by using insomnia severity index 3. Assessment of sleep quality by using Pittsburgh insomnia rating scale Timepoint: Baseline to End of Treatment (28 days)—

Countries

India

Contacts

Public ContactDr Harisha s

ICBio Clinical Research Pvt. Ltd.

harish@icbiocro.com9900111997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026