Health Condition 1: F489- Nonpsychotic mental disorder, unspecified
Conditions
Interventions
Intervention1: NRL/DST/19-20: Subjects will be advised to take NRL/DST/19-20 medication in a dose of 1 tab once at night for 28 days
Control Intervention1: Placebo: Subjects will be advised to take P
Sponsors
Netsurf Communications Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR). Insomnia Severity Index more than 7 and Subjects willing to sign inform consent form A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period. Willing to limit alcohol, caffeine, and nicotine consumption while in the study
Exclusion criteria
Exclusion criteria: Difficulty sleeping due to a medical condition History of a neurological disorder History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication On-going depression and generalized anxiety disorder (diagnosis on PHQ 9 and GAD 7 score scales) History of substance abuse or dependence on tobacco, alcohol Dependence of caffeine and caffeinated beverages History or current evidence of a clinically significant cardiovascular disorder at Pre study Visit Taking certain prohibited medications Consumption of >5 cigarettes a day History of malignancy Known hypersensitivity to any of the ingredients of Herbal formula Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in patient-reported total sleep time (as per patient diary) from baseline to end of the study Change in Sleep latency from baseline to end of the study Change in Sleep efficiency (Total sleep time/ time in bed X 100) derived from patient diary from day 30 to end of the study Change in serum cortisol levels from baseline to end of the studyTimepoint: Baseline Visit, Day 14, Day 28, Day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Patient-reported time to sleep onset, number of awakenings, wake time after sleep onset Change in Severity of Insomnia using Insomnia Severity Index Change in Daytime fatigue using Fatigue Severity Scale Change in Daytime mood, ability to function at work, concentration and memory on a graded scale Presence of rebound of insomnia on day 35 Changes in Quality of sleep on Pittsburgh Sleep Quality Index ,Grading on perceived stress scaleTimepoint: Baseline Visit, Day 14, Day 28, Day 35 | — |
Countries
India
Contacts
Public ContactDr Omkar Kulkarni
Netsurf Research Labs Pvt Ltd
Outcome results
None listed