Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: BSG along with Cognitive Behavioral Therapy for Insomnia (CBT-I): 2 BSG per day after dinner along with CBT-I for 2 weeks. Gummies
will be taken 30-60 minutes before going to bed.
Contr
Sponsors
Aesthetic Nutrition Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female aged 25-40 years (both inclusive) 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 less than 21 i.e. mild to moderate; 4. Subjects with a diagnosis of mild or moderate depression (patientsâ?? health questionnaire (PHQ-9) score of less than or equal to 14); 5. Subjects with a diagnosis of mild or moderate generalized anxiety disorder (GAD) -7 questionnaire score of less than or equal to 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. Willing to limit alcohol, caffeine, and nicotine consumption while in the study.
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 depression and generalized anxiety disorder (diagnosis on PHQ 9 score more than or equal to 15 and GAD-7 score more than or equal to 11 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 10 cigarettes a day; 9. History of malignancy less than or equal to 5 years prior to signing informed consent and current evidence of cancer;10. Known hypersensitivity to any ingredients of BSG; 11. 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. Subject-reported time to sleep onset (as per subject sleep diary) at day 7 and day 14. 2. Sleep latency (as per subject sleep diary) at day 7 and day 14. 3. Sleep efficiency (Total sleep time divided by time in bed into 100) derived from subject sleep diary at day 7 and day 14. 4. Sleep efficiency (Deep sleep, light sleep and REM sleep duration), overall sleep score by actigraphy for 10 subjects (5 subjects in each group) at screening and day 14.Timepoint: Screening Day, Visit 1(Day 1), Visit 2(Day 7), Visit 3(Day 14), Visit 4(Day 21) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Outcomes from subject sleep diary (Subject-reported total sleep time, Subject- reported number of awakenings, Subject -reported wake time after sleep onset) at day 7 and day 14. 2. Severity of insomnia using Insomnia Severity Index Scale at screening and day 14. 3. Daytime fatigue using Fatigue Severity Scale (FSS) at screening and day 14. 4. Measurements of stress on perceived stress scale at screening and day 14. 5. Measurement of mood on POMS scale (Profile of mood state questionnaire) at screening and day 14. 6. Cortisol and dopamine levels at screening and day 14.Timepoint: Screening Day, Visit 1(Day 1), Visit 2(Day 7), Visit 3(Day 14), Visit 4(Day 21) | — |
Countries
India
Contacts
Public ContactMs Ekta Pathania
Aesthetic Nutrition Pvt. Ltd.
Outcome results
None listed