Health Condition 1: Z733- Stress, not elsewhere classified
Conditions
Interventions
Intervention1: NBA-23: 1 tablet twice a day at an interval of 11-14 hours for 70 days
Control Intervention1: Placebo: 1 tablet twice a day at an interval of 11-14 hours for 70 days
Sponsors
Nisarga Biotech Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1)Participants aged greater than or equal to 30 and less than 60 years at the time of obtaining written informed consent;2)Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-V-TR);3)Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate;4)Subjects willing to sign inform consent form;5)A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout the study period;6)Subjects with a score of 14-26 on the Perceived Stress Scale (PSS);7)Willing to limit alcohol, caffeine, and nicotine consumption while in the study;8)Free of psychiatric conditions other than perceived stress.
Exclusion criteria
Exclusion criteria: 1.Difficulty sleeping due to a medical condition 2.History of a neurological disorder 3.History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication 4.On-going clinical depression and anxiety disorder (showing moderate to severe diagnosis on PHQ 9 and GAD 7 scales) 5.History of substance abuse or dependence 6.History or current evidence of a clinically significant cardiovascular disorder at Pre study Visit 7.Taking certain prohibited medications 8.Consumption of more than 15 cigarettes a day 9.History of malignancy less than or equal to 5 years prior to signing an informed consent 10.Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Perceived stress scale (PSS) score by perceived stress questionnaire will be assessed from screening to day 63 2.Cortisol and dopamine levels will be assessed at screening, day 28, day 63Timepoint: screening, baseline, day 28, day 36, and day 63 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of changes in- 1.Subject -reported time to sleep onset (as per subject diary), changes in sleep latency, sleep efficiency (Total sleep time divided by time in bed and multiplied by 100), and subject -reported number of awakenings derived from the subject diary at day 28, day 36 and day 63 2.Severity of insomnia using the Insomnia Severity Index Scale will be assessed from screening to day 63 3.Daytime fatigue using Fatigue Severity Scale (FSS) will be assessed from screening to day 63 4.Measurement of mood on the POMS scale (Profile of mood state questionnaire) will be assessed from screening to day 63 5.Changes in anxiety by using Hamilton Anxiety Rating Scale (HAM-A) score will be assessed from screening to day 63 Timepoint: screening, baseline, day 28, day 36, and day 63 | — |
Countries
India
Contacts
Public ContactMr Girish Soman
Mprex Healthcare Pvt Ltd
Outcome results
None listed