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 range18 Years – 40 Years
SexALL
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.
✓. Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days.
Exclusion criteria
✕. Subjects suffering from Insomnia.
✕. Subjects suffering from chronic fatigue, stress or anxiety.
✕. Subjects with uncontrolled hypertension with systolic blood pressure ≥130 and diastolic blood pressure ≥89 mm Hg.
✕. Subjects with uncontrolled Type II Diabetes Mellitus with FBG \>125 mg/ dl
✕. Subjects with Hemoglobin (Hb) ≤ and/or ≥ 13.5 - 17.0 g/Dl inmales and 12.0 - 15.0 g/dL in females.
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