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

NCT05586880 | Completed

• 1 other identifier: OM/220502/ENXTRA/RTPADF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Alert Fatigue, Health Personnel

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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 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

• 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

• 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

Study Arms (2)

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

Other: Experimental: EnXtra 300 mg/ capsule

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

Other: Microcrystalline cellulose (MCC) 300mg

Interventions

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

EnXtra 300 mg/ capsule

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

Microcrystalline cellulose (MCC) 300mg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (2)

Dr D Y Patil medical college

Nerul, Maharashtra, 400 706, India

Location

Dr. Sarala Kataria Clinic

Thane, Maharashtra, 400607, India

Location

MeSH Terms

Conditions

Alert Fatigue, Health Personnel

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Mental Fatigue; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Dr Shalini Srivastava, MD medicine

  Vedic Lifesciences Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sequentially numbered, sealed, opaque envelopes
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Crossover Trial

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 19, 2022
• Study Start: October 10, 2022
• Primary Completion: January 28, 2023
• Study Completion: January 28, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)