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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
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
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
Dr D Y Patil medical college
Nerul, Maharashtra, India
Dr. Sarala Kataria Clinic
Thane, Maharashtra, India
Reaction Accuracy
Reaction Accuracy as assessed by change in the accuracy score for the video game (Call of Duty) as compared to the placebo
Time frame: 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
Reaction Time as assessed by change in the time to response using stroop effect as compared to the placebo
Time frame: 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
Time taken to complete the mission for the video game (Call of Duty) as compared to the placebo
Time frame: 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
Stanford Sleepiness Scale
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.
Time frame: 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
Multidimensional Fatigue Inventory mental domain scores
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
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Time frame: 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
Multidimensional Fatigue Inventory physical domain scores
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
Time frame: 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
Multidimensional Fatigue Inventory (MFI) motivation domain scores
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
Time frame: 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