None listed
Conditions
Interventions
Intervention1: EnXtra® (300 mg) + Placebo (300 mg): Two capsules to be taken after breakfast orally once a day on 4 visit days during acute stage and for 28 days during sub-acute stage
Control Interve
Sponsors
Enovate Biolife Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and Females aged between 18 and 40 years. 2. Individuals who have night sleep of 8±1 hours. 3. Individuals with BMI more than or equal to 18 and less than or equal to 29.9 kg/m2. 4. Alertness score (Jin Fan’s ANT) of 50±20 ms after 24 hours of caffeine abstinence. 5. Individuals habituated to have at least 2 cups of coffee in a day. 6. Individuals with a feeling of sleepiness having Karolinska Sleepiness Scale (KSS) of more than 7 during caffeine abstinence. 7. Individuals who fit in physical examination, vital signs and all screening tests are within acceptable limits, according to the physician/investigator’s opinion. 8. Individuals having computer literacy to perform the required assessments. 9. Individuals willing to provide signed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals diagnosed with sleep disorders secondary to another health problem. 2. Individuals with a trait of excessive food cravings. 3. History of consumption of psychedelic drugs. 4. Individuals who are caffeine dependent i.e. having a history of more than 3 cups (more than or equal to 200 ml) in a day. 5. Individuals taking energy/ cognitive/ sedative supplements and are unwilling to stop taking those supplements for the duration of the study period. 6. Recent history of physical, emotional, and social trauma within the last three months. 7. Individuals who consume pain-relieving medications more than once per week. 8. Use of the following medications during the study period: oral or injectable corticosteroid, sedating antihistamines (e.g. cold, allergy, motion sickness), psychotropic medications or hypnotics, benzodiazepine, narcotics, or any illicit drugs. 9. Gastrointestinal, hepatic, respiratory, psychiatric, kidney, or cardiovascular disorder (less than 3 months before inclusion). 10. Recent (less than 3 months before inclusion) change in lifestyle (food, body weight, sport, drug, and dietary supplement). 11. Addiction or history of substance abuse. 12. Consumption of more than 3 units of alcohol per day. (one unit is equal to 45 ml of hard liquor, 150 ml of wine or a pint of beer). 13. Abnormal Thyroid Stimulating Hormone (TSH) value which is less than 0.40 or more than 5.0 micro IU/mL. 14. Known Diabetics. 15. Hypertensives defined as SBP more than 140 mm Hg and/or DBP more than 90 mm Hg with or without anti-hypertensives. 16. Use another investigational product within 90 days of the screening visit. 17. Individuals with a history of or complications from malignant tumors. 18. History of any significant neurological and psychiatric condition that may affect the participation and inference of the study endpoints. 19. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 20. Any condition that could, in the opinion of the investigator, preclude the individual ability to successfully and safely complete the study or that may confound study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeineTimepoint: Day 0; Day 5; Day 10; Day 15 – 0, 1, 3 & 5 hours ±15 minutes post IP in acute stage and Day 20 – 0 hours, Day 48 – 1, 3 & 5 hours ±15 minutes post IP in sub-acute stage. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the effect of EnXtra® and EnXtra® + Caffeine on Eye-hand coordination as assessed by Nine hole peg test (NHPT) as compared to placebo and caffeine in acute stageTimepoint: Day 0; Day 5; Day 10; Day 15 – 0, 1, 3 & 5 hours ±15 minutes’ post IP;To determine the effect of EnXtra® and EnXtra® + Caffeine on Sustained attention as assessed by Continuous Performance test (CPT) as compared to placebo and caffeine in Acute stage.Timepoint: Day 0; Day 5; Day 10; Day 15 – 0, 1, 3 & 5 hours ±15 minutes’ post IP;To determine the effect of EnXtra® and EnXtra® + Caffeine on Fatigue as assessed by the change in the Samn-Perelli fatigue scale (SPS) compared to placebo and caffeine in Acute stage.Timepoint: Day 0; Day 5; Day 10; Day 15 – 0, 1, 3 & 5 hours ±15 minutes’ post IP;To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the complete metabolic panel [Complete blood cell (CBC), Liver function test (LFT) & Kidney function test (KFT)] in acute stage.Timepoint: On screening visit;To determine the effect of EnXtra® and EnXtra® + Caffeine on Eye-hand coordination as assessed by Nine hole peg test (NHPT) in sub-acute stage.Timepoint: Day 20 – 0 hours, Day 48 – 1, 3 & 5 hours ± 15 minutes post last dose;To determine the effect of EnXtra® and EnXtra® + Caffeine on Sustained attention as assessed by Continuous Performance test (CPT) in sub-acute stageTimepoint: Day 20 – 0 hours, Day 48 – 1, 3 & 5 hours ± 15 minutes post last dose;To determine the effect of EnXtra® and EnXtra® + Caffeine on Fatigue as assessed by the change in the Samn-Perelli fatigue scale (SPS) compared to placebo and caffeine.Timepoint: Day 20 – 0 hours, Day 48 – 1, 3 & 5 hours ± 15 minutes post last dose;To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the complete metabolic panel [Complete blood cell (CBC), Liver function test (LFT) & Kidney function test (KFT)] in sub acute stageTimepoint: Day 48 | — |
Countries
India
Contacts
Public ContactDr Sonali Ghosh
Vedic Lifesciences Pvt. Ltd.
Outcome results
None listed