Study to Evaluate Efficacy of EnXtra on Accuracy & Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers
NCT05586880, Not applicable, Completed, Vedic Lifesciences Pvt. Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Study to Evaluate Efficacy of EnXtra on Accuracy & Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers | ClinicalTrials.gov |
| NCT number | NCT05586880 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Vedic Lifesciences Pvt. Ltd. | ClinicalTrials.gov |
| Conditions | Alert Fatigue, Health Personnel | ClinicalTrials.gov |
| Interventions | Experimental: EnXtra 300 mg/ capsule, Microcrystalline cellulose (MCC) 300mg | ClinicalTrials.gov |
| First posted | 2022-10-19 | ClinicalTrials.gov |
| Last updated | 2023-03-24 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Reaction Accuracy | 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 | ClinicalTrials.gov |
| Primary | Reaction 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 | Reaction Time as assessed by change in the time to response using stroop effect as compared to the placebo | ClinicalTrials.gov |
| Secondary | 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 | Time taken to complete the mission for the video game (Call of Duty) as compared to the placebo | ClinicalTrials.gov |
| Secondary | 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 | 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. | ClinicalTrials.gov |
| Secondary | 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 | 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 | ClinicalTrials.gov |
| Secondary | 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 | 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 | ClinicalTrials.gov |
| Secondary | 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 | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)