Study to Evaluate Efficacy of EnXtra on Accuracy & Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers

Vedic Lifesciences

Status

Completed

Conditions

Alert Fatigue, Health Personnel

Treatments

Other: Microcrystalline cellulose (MCC) 300mg

Other: Experimental: EnXtra 300 mg/ capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT05586880

OM/220502/ENXTRA/RTPADF

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.
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.

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.
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.