NCT05586880已完成不适用
A Randomized, Placebo-controlled, Double-blind Crossover Study to Evaluate Efficacy of EnXtra on Accuracy & Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Reaction Accuracy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Sequentially numbered, sealed, opaque envelopes
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Subjects willing to refrain from consuming caffeine and caffeine-containing products 24 hour prior to visit days.
- •Willing to participate in the study with a signed and dated written consent.
排除标准
- •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.
- •Subjects with ≤ and/or ≥ Total Leucocyte Counts (TLC) 4.0 - 10.0 x 10 3/U
- •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 %]
- •Subjects with AST values ≤ and/or ≥ 40 U/L in males and 32 U/Lin females.
- •Subjects with ALT values ≤ and/or ≥ 41 U/L in males and 33 U/Lin females
- •Subjects with Creatinine ≤ and/or ≥ Males: 59-104 μmol/L in males and 45-84 μmol/L in females
- •History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders.
- •Chronic Alcoholics and smokers
- •Subjects taking any medications or preparations to improve gaming performance (herbal, dietary supplements, homeopathic preparations, etc.) and/or cognitive performance during the study.
- •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.
- •Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications.
- •Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- •Subjects who have had participated in a study of an investigational product 90 days prior to the screening.
结局指标
主要结局
Reaction Accuracy
时间窗: 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
时间窗: 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
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
研究者
研究点 (4)
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