Alert Fatigue, Health Personnel
Conditions
Brief summary
In the present study, Sponsor aim to evaluate the effects of EnXtra® as to improve Accuracy & Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers. A Randomized, Placebo-controlled, Double-blind Crossover Study of 60 randomized cross over for total study duration of approximately 25 days with 5 days of treatment period for each arm and 5-7 days wash out period between both arms.
Interventions
OTHERExperimental: EnXtra 300 mg/ capsule
One capsule to be taken 3±0.5 hours prior to second gaming session on Day 1 followed by 1 capsule daily after breakfast for 5 days
OTHERMicrocrystalline cellulose (MCC) 300mg
One capsule to be taken 3±0.5 hours prior to second gaming session on Day 1 followed by 1 capsule daily after breakfast for 5 days
Sponsors
Vedic Lifesciences Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Sequentially numbered, sealed, opaque envelopes
Intervention model description
Randomized, Crossover Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males & Females aged ≥ 18 - ≤ 40 years. 2. Subjects with Body Mass Index (BMI) 18 - 29.9 kg/ m2 3. Subjects with history of playing video games for 6 or more hours/ week for 6 months before the screening 4. Subject who can read and understand English language with ease. 5. Fasting blood glucose (FBG) ≤ 125 mg/dl 6. Subjects with history of regular sleep and agree to sleep for 8 ±1 hours the night before the visit day. 7. Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period. 8. Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days. 9. Subjects willing to refrain from consuming caffeine and caffeine-containing products 24 hour prior to visit days. 10. Willing to participate in the study with a signed and dated written consent.
Exclusion criteria
1. Subjects suffering from Insomnia. 2. Subjects suffering from chronic fatigue, stress or anxiety. 3. Subjects with uncontrolled hypertension with systolic blood pressure ≥130 and diastolic blood pressure ≥89 mm Hg. 4. Subjects with uncontrolled Type II Diabetes Mellitus with FBG \>125 mg/ dl 5. Subjects with Hemoglobin (Hb) ≤ and/or ≥ 13.5 - 17.0 g/Dl inmales and 12.0 - 15.0 g/dL in females. 6. Subjects with ≤ and/or ≥ Total Leucocyte Counts (TLC) 4.0 - 10.0 x 10 3/U 7. Subjects with Differential Leukocyte Counts (DLC) outside the normal range. \[Neutrophils: 40 - 80 %, Lymphocytes: 20 - 40 %, Monocytes: 2 - 10 %, Eosinophils: 1 - 6 %, Basophils: 0 - 0.02 %\] 8. Subjects with AST values ≤ and/or ≥ 40 U/L in males and 32 U/Lin females. 9. Subjects with ALT values ≤ and/or ≥ 41 U/L in males and 33 U/Lin females 10. Subjects with Creatinine ≤ and/or ≥ Males: 59-104 μmol/L in males and 45-84 μmol/L in females 11. History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders. 12. Chronic Alcoholics and smokers 13. Subjects taking any medications or preparations to improve gaming performance (herbal, dietary supplements, homeopathic preparations, etc.) and/or cognitive performance during the study. 14. Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator may interfere with evaluations in the study or noncompliance with treatment or visits. 15. Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications. 16. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 17. Subjects who have had participated in a study of an investigational product 90 days prior to the screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reaction Accuracy | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP & 3 hours post IP on Day 5; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & 3 hours post IP on Day 15 | Reaction Accuracy as assessed by change in the accuracy score for the video game (Call of Duty) as compared to the placebo |
| Reaction Time | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP & 3 hours post IP on Day 5; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & 3 hours post IP on Day 15 | Reaction Time as assessed by change in the time to response using stroop effect as compared to the placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional Fatigue Inventory mental domain scores | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP & Day 5 - 3 hours post IP; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & Day 15 - 3 hours post IP | Mental fatigue as assessed by change in Multidimensional Fatigue Inventory (MFI) mental domain scores at the end of the video game, as compared to the placebo The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This tool has been tested for its psychometric properties in individuals receiving radiotherapy, those with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians |
| TIME | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP & 3 hours post IP on Day 5; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & 3 hours post IP on Day 15 | Time taken to complete the mission for the video game (Call of Duty) as compared to the placebo |
| Multidimensional Fatigue Inventory (MFI) motivation domain scores | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP, Day 5 - 3 hours post IP; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & Day 15 - 3 hours post IP | Intrinsic motivation for video gaming as assessed by change in the Multidimensional Fatigue Inventory (MFI) motivation domain scores after game session, as compared to placebo. The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This tool has been tested for its psychometric properties in individuals receiving radiotherapy, those with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians |
| Multidimensional Fatigue Inventory physical domain scores | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP, Day 5 - 3 hours post IP; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & Day 15 - 3 hours post IP | Physical fatigue as assessed by change in Multidimensional Fatigue Inventory (MFI) physical domain score at the end of the video game, as compared to the placebo The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This tool has been tested for its psychometric properties in individuals receiving radiotherapy, those with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians |
| Stanford Sleepiness Scale | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP & Day 5 - 3 hours post IP; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & Day 15 - 3 hours post IP | Perceived Alertness after video game assessed by change in Stanford Sleepiness Scale (SSS) after video game session, as compared to that of placebo Higher the score is the worst outcome and lowest the score is the better outcome. |
Countries
India
Outcome results
None listed