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Clinical Trials/CTRI/2024/03/063637
CTRI/2024/03/063637
Recruiting
Phase 2

A pilot clinical study to evaluate efficacy and safety of 3 different formulations in healthy participants with insomnia - NI

SciTech Specialties Pvt. Ltd.0 sites0 target enrollmentTBD

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
SciTech Specialties Pvt. Ltd.
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
SciTech Specialties Pvt. Ltd.

Eligibility Criteria

Inclusion Criteria

  • 1\. Participants having average (average of three night readings before baseline visit) sleep initiation greater than or equal to 30 minutes and effective sleep duration of less than or equal to 6 hours on Ballistocardiography
  • 2\. Participants diagnosed with insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM V TR)
  • 3\. Insomnia Severity Index score more than 7 and less than or equal to 21
  • 4\. Participants willing to sign inform consent form and ready to follow the study protocol requirements
  • 5\. Female participants with reproductive potential with a negative pregnancy test (Urine) and agree to use contraception throughout study period
  • 6\. Participants willing to stop alcohol, caffeine, and nicotine consumption while in the study

Exclusion Criteria

  • Participants with history or diagnosis of secondary sleep disorder (any other underlying medical or surgical condition diagnosed on the basis of history and clinical examination by the investigator)
  • 2\.Participants with history of any neurological disorder causing interference in sleep
  • 3\.Participants with history of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication
  • 4\.Participants with on going depression and generalized anxiety disorder treatment
  • 5\.Participants with history of substance abuse or dependence for the last 5 years
  • 6\.Participants taking certain prohibited medications like opium, cannabis (marijuana) and methamphetamines etc.
  • 7\.Participants with habit of smoking Cigarette etc. (More than 5 cigarettes per day)
  • 8\.Participants with known history of hepatitis B and or C
  • 9\.Participants with history of malignancy less than or equal to 5 years prior to study participation
  • 10\.Participants with known hypersensitivity to any of the ingredients of study products

Outcomes

Primary Outcomes

Not specified

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