Study to Evaluate Efficacy of EnXtra on Accuracy & Reaction Time, Perceived Alertness & Digital F… (NCT05586880) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate Efficacy of EnXtra on Accuracy & Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers
India60 participantsStarted 2022-10-10
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males \& Females aged ≥ 18 - ≤ 40 years.
. Subjects with Body Mass Index (BMI) 18 - 29.9 kg/ m2
. Subjects with history of playing video games for 6 or more hours/ week for 6 months before the screening
. Subject who can read and understand English language with ease.
. Fasting blood glucose (FBG) ≤ 125 mg/dl
. Subjects with history of regular sleep and agree to sleep for 8 ±1 hours the night before the visit day.
. Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reaction Accuracy
Timeframe: 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
2
Reaction Time
Timeframe: 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