Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: Sleepnite Tablet with CBT-I (Cognitive Behavioral Therapy for Insomnia): One Sleepnite tablet daily after dinner for 60 days
Control Intervention1: Placebo with CBT-I (Cognitive Behavio
Sponsors
Meyer Organics Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants aged greater than or equal to 18 and less than or equal to 65 years of both sex at the time of obtaining written informed consent; 2. Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-V-TR); 3. Insomnia Severity Index more than 7 and 4. Patients with a diagnosis of Mild or moderate depression (Patients’ health questionnaire (PHQ-9) score of =14); 5. Patients with a diagnosis of Mild or moderate Generalized anxiety disorder (Generalized anxiety disorder (GAD) -7 questionnaire score of =10); 6. Subjects willing to sign inform consent form; 7. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period; 8. No history of substance use disorder other than use of nicotine and recreational use of alcohol (not having used for the last 14 days and consenting not to use the same during the period of the trial); 9. Willing to limit caffeine consumption while in the study.
Exclusion criteria
Exclusion criteria: 1. Difficulty sleeping due to a medical condition; 2. History of a neurological disorder; 3. Lifetime history of severe mental illness; 4. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires sedating medication; 5. On-going depression and generalized anxiety disorder (diagnosis on PHQ 9 score =15 and GAD 7 score =11 scales); 6. History of substance abuse or dependence; 7. History or current evidence of a clinically significant cardiovascular disorder at pre study visit; 8. Taking certain prohibited medications; 9. Consumption of >15 cigarettes a day; 10. History of malignancy =5 years prior to signing informed consent; 11. Known hypersensitivity to any of the ingredients of Sleepnite tablet; 12. 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 |
|---|---|
| 1.Patient-reported total sleep time (as per patient diary). 2.Sleep latency (as per patient diary). 3.Sleep efficiency (Total sleep time divided by time in bed multiplied by 100) derived from patient diary.Timepoint: Screening, Day 30 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Outcomes from patient diary (Patient-reported total sleep time, Patient- reported number of awakenings, Patient -reported wake time after sleep onset). 2.Severity of Insomnia using Insomnia Severity Index Scale. 3.Daytime fatigue score using Fatigue Severity Scale (FSS). 4.Measurements of stress score on perceived stress scale. Measurement of mood score on POMS scale (Profile of mood state questionnaire). Timepoint: Screening, Day 30 and Day 60 | — |
Countries
India
Contacts
Public ContactNeepa Gaba
Meyer Organics Pvt. Ltd.
Outcome results
None listed