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.
Investigators
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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