None listed
Conditions
Interventions
Intervention1: Melatonin 5mg + Jatamansi Extract 5mg OD-EffTabs: 1 Tablet at bed time daily with water for 30 days.
Control Intervention1: Chammomile Flower Extract 35mg + Melatonin 5mg OD-EffTabs: 1
Sponsors
SciTech Specialties Pvt. Ltd.
Eligibility
Inclusion 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
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 11. Participants with other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his or her participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in sleep parameters (Time in bed, sleep initiation, effective sleep duration, Sleep continuity (Awakenings), tossing and turning, light sleep, NREM (non rapid eye movement) sleep, REM (rapid eye movement) sleep, Average Resting Breathing Rate (bpm), Max Resting Breathing Rate (bpm), Average Resting Heart Rate (bpm), Max Resting Heart Rate (bpm) using BallistocardiographyTimepoint: Screening Visit (up to 3 days), Day 0, Day 15 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in severity of Insomnia using Insomnia Severity Index 2. Change in quality of sleep on Pittsburgh Sleep Quality Index 3. Change in stress on perceived stress scale 4. Change in daytime fatigue using Fatigue Severity Scale 5. Change in daytime mood, ability to function at work, concentration, and memory on a graded scale 6. Change in participant reported total sleep time (as per participant diary) 7. Change in sleep efficiency, Time to sleep onset. Number of awakenings, Wake time after sleep onset based on participant diary 8. Global assessment for overall change by investigator and by participant 9. Assessment of tolerability of study products by assessing adverse events 10. Assessment of Laboratory related safety investigations Timepoint: Screening Visit (up to 3 days), Day 0, Day 15 and Day 30 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd.
Outcome results
None listed