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Alert Fatigue, Health PersonnelNCT05586880

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

A study testing Experimental: EnXtra 300 mg/ capsule and Microcrystalline cellulose (MCC) 300mg in people with Alert Fatigue, Health Personnel, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Alert Fatigue, Health Personnel
What is being tested?
Experimental: EnXtra 300 mg/ capsule and Microcrystalline cellulose (MCC) 300mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
2 sitesIndia
Study dates
10 Oct 2022to 28 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

2 sites in 1 country.

India2 sites

  • Dr D Y Patil medical college

    Nerul, Maharashtra, 400 706

  • Dr. Sarala Kataria Clinic

    Thane, Maharashtra, 400607

Other trials in India

About this study

Official title: A Randomized, Placebo-controlled, Double-blind Crossover Study to Evaluate Efficacy of EnXtra on Accuracy & Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers

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.

Being tested
Experimental: EnXtra 300 mg/ capsule, Microcrystalline cellulose (MCC) 300mg
Medical subject headings
Alert Fatigue, Health Personnel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: EnXtra 300 mg/ capsuleOther

    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) 300mgOther

    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

Study groups in NCT05586880
Study groupRoleWhat they receive
EnXtra 300 mg/ capsuleExperimentalOne 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
Receives: Other: Experimental: EnXtra 300 mg/ capsule
Microcrystalline cellulose (MCC) 300mgPlacebo comparatorOne 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
Receives: Other: Microcrystalline cellulose (MCC) 300mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reaction Accuracy

    Reaction Accuracy as assessed by change in the accuracy score for the video game (Call of Duty) as compared to the placebo

    Measured: 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

    Reaction Time as assessed by change in the time to response using stroop effect as compared to the placebo

    Measured: 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)

  1. TIME

    Time taken to complete the mission for the video game (Call of Duty) as compared to the placebo

    Measured: 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. Stanford Sleepiness Scale

    Perceived Alertness after video game assessed by change in Stanford Sleepiness Scale (SSS) after video game session, as compared to that of placebo

    Higher the score is the worst outcome and lowest the score is the better outcome.

    Measured: 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

  3. Multidimensional Fatigue Inventory mental domain scores

    Mental fatigue as assessed by change in Multidimensional Fatigue Inventory (MFI) mental domain scores at the end of the video game, as compared to the placebo The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This tool has been tested for its psychometric properties in individuals receiving radiotherapy, those with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians

    Measured: 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

  4. Multidimensional Fatigue Inventory physical domain scores

    Physical fatigue as assessed by change in Multidimensional Fatigue Inventory (MFI) physical domain score at the end of the video game, as compared to the placebo The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This tool has been tested for its psychometric properties in individuals receiving radiotherapy, those with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians

    Measured: 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

  5. Multidimensional Fatigue Inventory (MFI) motivation domain scores

    Intrinsic motivation for video gaming as assessed by change in the Multidimensional Fatigue Inventory (MFI) motivation domain scores after game session, as compared to placebo.

    The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This tool has been tested for its psychometric properties in individuals receiving radiotherapy, those with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start10 Oct 2022
  3. Primary completion28 Jan 2023
  4. Study completion28 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized, Crossover Trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586880
Sponsor's protocol ID
OM/220502/ENXTRA/RTPADF
Status last verified
Mar 2023
First submitted
14 Oct 2022
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: EnXtra 300 mg/ capsule and Microcrystalline cellulose (MCC) 300mg in people with Alert Fatigue, Health Personnel, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reaction Accuracy (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05586880.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.

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