None listed
Conditions
Interventions
Intervention1: ITC-SLB 1: Oral administration of ITC-SLB 1 two per day for 7 days.
Control Intervention1: ITC-SLB 2: Oral Administration of ITC-SLB 2 two per day for 7 days
Sponsors
ITC Life Sciences and Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Urban individuals with NCCS rating of Lower A (A2 and A3) and Higher B (B1) grades 3 2. PSQI scores between 5-15 3. Can read and write English. 4. No history of psychiatric conditions 5. Should be ready to abstain from alcohol consumption, smoking and consumption of caffeinated beverages. 6. Should be willing to adhere with their routine diet and exercise regimen throughout the study. 7. Must be willing and able to give informed consent and comply with the study procedures
Exclusion criteria
Exclusion criteria: Subject suffering from mental disorders, clinical anxiety, depression, Cushingââ?¬•s syndrome and other major ailments. 2. Subjects on medication/dietary supplements that may affect the measured responses, including medicines for anxiety, depression; prednisone, dexamethasone and other steroids administered orally or intravenous 3. Alcohol addicts, smokers of more than 10 cigarettes/day. 4. Pregnant and lactating women 5. Subjects on hormonal birth-control measures Subjects currently on any medication on a regular basis. 7. Subjects allergic to herbal products, nuts or any component of the study product 8. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 9. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Actigraphy and Sleep Quality questionnaire scores in comparison with baselineTimepoint: Day 0, Day 8, Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety AssessmentTimepoint: Day 0, Day 1, Day 7, Day 8, Day 13, Day 14;Salivary Melatonin levelTimepoint: Day 0, Day 1, Day 7, Day 8, Day 13, Day 14 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Private Limited
Outcome results
None listed