Clinical trial NCT05586880: Study to Evaluate Efficacy of EnXtra on Accuracy & Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alert Fatigue, Health Personnel
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, Crossover Trial
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. Males \& Females aged ≥ 18 - ≤ 40 years.
2. Subjects with Body Mass Index (BMI) 18 - 29.9 kg/ m2
3. Subjects with history of playing video games for 6 or more hours/ week for 6 months before the screening
4. Subject who can read and understand English language with ease.
5. Fasting blood glucose (FBG) ≤ 125 mg/dl
6. Subjects with history of regular sleep and agree to sleep for 8 ±1 hours the night before the visit day.
7. Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period.
8. Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days.
9. Subjects willing to refrain from consuming caffeine and caffeine-containing products 24 hour prior to visit days.
10. Willing to participate in the study with a signed and dated written consent.

Exclusion Criteria:

1. Subjects suffering from Insomnia.
2. Subjects suffering from chronic fatigue, stress or anxiety.
3. Subjects with uncontrolled hypertension with systolic blood pressure ≥130 and diastolic blood pressure ≥89 mm Hg.
4. Subjects with uncontrolled Type II Diabetes Mellitus with FBG \>125 mg/ dl
5. Subjects with Hemoglobin (Hb) ≤ and/or ≥ 13.5 - 17.0 g/Dl inmales and 12.0 - 15.0 g/dL in females.
6. Subjects with ≤ and/or ≥ Total Leucocyte Counts (TLC) 4.0 - 10.0 x 10 3/U
7. Subjects with Differential Leukocyte Counts (DLC) outside the normal range. \[Neutrophils: 40 - 80 %, Lymphocytes: 20 - 40 %, Monocytes: 2 - 10 %, Eosinophils: 1 - 6 %, Basophils: 0 - 0.02 %\]
8. Subjects with AST values ≤ and/or ≥ 40 U/L in males and 32 U/Lin females.
9. Subjects with ALT values ≤ and/or ≥ 41 U/L in males and 33 U/Lin females
10. Subjects with Creatinine ≤ and/or ≥ Males: 59-104 μmol/L in males and 45-84 μmol/L in females
11. History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders.
12. Chronic Alcoholics and smokers
13. Subjects taking any medications or preparations to improve gaming performance (herbal, dietary supplements, homeopathic preparations, etc.) and/or cognitive performance during the study.
14. 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.
15. Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications.
16. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
17. Subjects who have had participated in a study of an investigational product 90 days prior to the screening.

Primary outcomes:
measure: Reaction Accuracy
timeFrame: 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
measure: Reaction Time
timeFrame: 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:
measure: TIME
timeFrame: 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
measure: Stanford Sleepiness Scale
timeFrame: 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
measure: Multidimensional Fatigue Inventory mental domain scores
timeFrame: 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
measure: Multidimensional Fatigue Inventory physical domain scores
timeFrame: 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
measure: Multidimensional Fatigue Inventory (MFI) motivation domain scores
timeFrame: 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
Other outcomes:
Locations:
city: Nerul
country: India
facility: Dr D Y Patil medical college
state: Maharashtra
city: Thāne
country: India
facility: Dr. Sarala Kataria Clinic
state: Maharashtra
Study officials:
affiliation: Vedic Lifesciences Pvt. Ltd.
name: Dr Shalini Srivastava, MD medicine
role: PRINCIPAL_INVESTIGATOR
References: