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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EnXtra 300 mg/ capsule | Experimental | 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 |
|
| Microcrystalline cellulose (MCC) 300mg | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: EnXtra 300 mg/ capsule | Other | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reaction Accuracy | Reaction Accuracy as assessed by change in the accuracy score for the video game (Call of Duty) as compared to the placebo | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| TIME | Time taken to complete the mission for the video game (Call of Duty) as compared to the placebo | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Shalini Srivastava, MD medicine | Vedic Lifesciences Pvt. Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr D Y Patil medical college | Nerul | Maharashtra | 400 706 | India | ||
| Dr. Sarala Kataria Clinic |
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Randomized, Crossover Trial
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Sequentially numbered, sealed, opaque envelopes
| Microcrystalline cellulose (MCC) 300mg | Other | 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 |
|
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. |
| 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 | 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 | 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 | 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 |
| Thane |
| Maharashtra |
| 400607 |
| India |
| ID | Term |
|---|---|
| D000071064 | Alert Fatigue, Health Personnel |
| ID | Term |
|---|---|
| D005222 | Mental Fatigue |
| D005221 | Fatigue |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
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