FatigueNCT06560008

A Study to Evaluate the Effect of EnXtra® and EnXtra® + Caffeine on Mental Alertness and Fatigue in Healthy Individuals

A study testing EnXtra® (300 mg) + Caffeine (200 mg) in people with Fatigue and Mental Alertness, run by Vedic Lifesciences Pvt. Ltd. at 3 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

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Fatigue, Mental Alertness
What is being tested?: EnXtra® (300 mg) + Caffeine (200 mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 128 participants
Where: 3 sitesIndia
Study dates: 10 Oct 2024to 21 Mar 2025
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 and females aged between 18 and 40 years.
Individuals who have night sleep of 8±1 hours.
Individuals with BMI ≥ 18 and ≤ 29.9 kg/meter square
Alertness score (Jin Fan's ANT) of 50±20 ms after 24 hours of caffeine abstinence.
Individuals habituated to have at least 2 cups of coffee in a day.
Individuals with a feeling of sleepiness having Karolinska Sleepiness Scale (KSS) of more than 7 during caffeine abstinence.

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Individuals who fit in physical examination, vital signs and all screening tests are within acceptable limits, according to the physician/investigator's opinion.
Individuals having computer literacy to perform the required assessments.
Individuals willing to provide signed consent.

Who cannot join

Individuals diagnosed with sleep disorders secondary to another health problem.
Individuals with a trait of excessive food cravings.
History of consumption of psychedelic drugs.
Individuals who are caffeine dependent i.e. having a history of more than 3 cups (≥200 ml) in a day.
Individuals taking energy/ cognitive/ sedative supplements and are unwilling to stop taking those supplements for the duration of the study period.
Recent history of physical, emotional, and social trauma within the last three months.

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Individuals who consume pain-relieving medications more than once per week.
Use of the following medications during the study period: oral or injectable corticosteroid, sedating antihistamines (e.g. cold, allergy, motion sickness), psychotropic medications or hypnotics, benzodiazepine, narcotics, or any illicit drugs.
Gastrointestinal, hepatic, respiratory, psychiatric, kidney, or cardiovascular disorder (<3 months before inclusion).
Recent (<3 months before inclusion) change in lifestyle (food, body weight, sport, drug, and dietary supplement).
Addiction or history of substance abuse.
Consumption of more than 3 units of alcohol per day. (one unit is equal to 45 ml of hard liquor, 150 ml of wine or a pint of beer)
Abnormal Thyroid Stimulating Hormone (TSH) value which is less than 0.40 or more than 5.0 μIU/mL.
Known Diabetics.
Hypertensives defined as SBP more than 140 mm Hg and/or DBP more than 90 mm Hg with or without anti-hypertensives.
Use another investigational product within 90 days of the screening visit.
Individuals with a history of or complications from malignant tumors.
History of any significant neurological and psychiatric condition that may affect the participation and inference of the study's endpoints.
Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
Any condition that could, in the opinion of the investigator, preclude the individual's ability to successfully and safely complete the study or that may confound study outcomes.

Trial locations and contacts

3 sites in 1 country.

India3 sites

New Manak Healcare Hospital
Navi Mumbai, Maharashtra, 400706
Gurukrupa Hospital
Thane, Maharashtra, 400601
Kalpana Hospital
Thane, Maharashtra, 400601

Other trials in India

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of EnXtra® and EnXtra® + Caffeine on Mental Alertness and Fatigue in Healthy Individuals

Acute Stage: The present study is a randomized, double-blind, placebo-controlled, single-dose, 4-way, cross-over, study. Approximately not more than 170 individuals will be screened and considering a screening failure rate of 25%, approximately 128 individuals will be randomized in a ratio of 1:1:1:1 to receive one of the IPs and will be assigned a unique randomization code. In this stage, approximately 114 individuals will complete the study, after accounting for a dropout/withdrawal rate of 15%. The intervention duration is 4 days [1 (single dose) x 4 periods].

Sub-Acute Stage: The present study is a randomized, double-blind, placebo-controlled, 4 arms, parallel study. In this stage, approximately 112 individuals will be re-randomized in a ratio of 1:1:1:1 to receive one of the IPs and will be assigned a unique randomization code. Each group will have not less than 24 completed participants after accounting for a dropout/withdrawal rate of 15%. The intervention duration is 28 days.

Conditions: Fatigue, Mental Alertness
Being tested: EnXtra® (300 mg) + Placebo (300 mg), Caffeine (200 mg) + Placebo (300 mg), EnXtra® (300 mg) + Caffeine (200 mg), Placebo (MCC 300 mg) + Placebo (300 mg)
Medical subject headings: Fatigue

What participants receive

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

EnXtra® (300 mg) + Placebo (300 mg)Dietary supplement
Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)
Caffeine (200 mg) + Placebo (300 mg)Dietary supplement
Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)
EnXtra® (300 mg) + Caffeine (200 mg)Dietary supplement
Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)
Placebo (MCC 300 mg) + Placebo (300 mg)Dietary supplement
Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)

Study groups in NCT06560008
Study group	Role	What they receive
EnXtra® (300 mg) + Placebo (300 mg)	Active comparator	Acute Stage: Two capsules to be taken after breakfast orally 1 (single dose) x 4 periods = 4 days Sub-acute Stage: Two capsules to be taken after breakfast orally once a day for 28 days Receives: Dietary Supplement: EnXtra® (300 mg) + Placebo (300 mg)
Caffeine (200 mg) + Placebo (300 mg)	Active comparator	Acute Stage: Two capsules to be taken after breakfast orally 1 (single dose) x 4 periods = 4 days Sub-acute Stage: Two capsules to be taken after breakfast orally once a day for 28 days Receives: Dietary Supplement: Caffeine (200 mg) + Placebo (300 mg)
EnXtra® (300 mg) + Caffeine (200 mg)	Active comparator	Acute Stage: Two capsules to be taken after breakfast orally 1 (single dose) x 4 periods = 4 days Sub-acute Stage: Two capsules to be taken after breakfast orally once a day for 28 days Receives: Dietary Supplement: EnXtra® (300 mg) + Caffeine (200 mg)
Placebo (MCC 300 mg) + Placebo (300 mg)	Placebo comparator	Acute Stage: Two capsules to be taken after breakfast orally 1 (single dose) x 4 periods = 4 days Sub-acute Stage: Two capsules to be taken after breakfast orally once a day for 28 days Receives: Dietary Supplement: Placebo (MCC 300 mg) + Placebo (300 mg)

What is being measured

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

To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage.
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks.
Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears.
Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up.
Centre cue condition, A cue appears at the screen's center just before the target stimulus.
Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction.
Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
Measured: Day 0 at 0, 1, 3 and 5 hours ± 15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage.
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks.
Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears.
Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up.
Centre cue condition, A cue appears at the screen's center just before the target stimulus.
Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction.
Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
Measured: Day 5 at 0, 1, 3 and 5 hours ± 15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage.
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks.
Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears.
Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up.
Centre cue condition, A cue appears at the screen's center just before the target stimulus.
Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction.
Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
Measured: Day 10 at 0, 1, 3 and 5 hours ± 15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage.
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks.
Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears.
Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up.
Centre cue condition, A cue appears at the screen's center just before the target stimulus.
Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction.
Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
Measured: Day 15 at 0, 1, 3 and 5 hours ± 15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Sub-acute stage.
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks.
Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears.
Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up.
Centre cue condition, A cue appears at the screen's center just before the target stimulus.
Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction.
Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
Measured: Day 20 at 0 hours post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Sub-acute stage.
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks.
Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears.
Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up.
Centre cue condition, A cue appears at the screen's center just before the target stimulus.
Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction.
Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
Measured: Day 48 at 1, 3 and 5 hours ± 15 minutes post IP

Secondary outcomes (9)

To determine the effect of EnXtra® and EnXtra® + Caffeine on Eye-hand coordination as assessed by Nine hole peg test (NHPT) as compared to placebo and caffeine in Acute stage.
The NHPT assesses eye-hand coordination in individuals. This study focuses on the dominant hand's performance.
Metrics recorded for assessment:
Moving Duration - 1: Time to move the first peg from the holder to the board, indicating initial movement speed and fluidity.
First Peg Selection - 1: Time from the start of the test until the first peg is picked up, indicating readiness and initial response speed.
Transport Drops - 1: Number of times the first peg is dropped during transport, assessing precision and control.
Moving Duration - 2: Similar to Moving Duration - 1 for the second peg, providing insight into consistency and endurance over multiple attempts.
First Peg Selection - 2: Time taken to select the first peg again, measuring sustained attention and readiness.
Transport Drops - 2: No. of drops during the second transport attempt, evaluating precision and control.
An increase in moving duration indicates a decline in eye-hand coordination speed.
Measured: Day 0; Day 5; Day 10; Day 15 - 0, 1, 3 & 5 hours ±15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on Eye-hand coordination as assessed by Nine hole peg test (NHPT) as compared to placebo and caffeine in Sub-acute stage.
The NHPT assesses eye-hand coordination in individuals. This study focuses on the dominant hand's performance.
Metrics recorded for assessment:
Moving Duration - 1: Time to move the first peg from the holder to the board, indicating initial movement speed and fluidity.
First Peg Selection - 1: Time from the start of the test until the first peg is picked up, indicating readiness and initial response speed.
Transport Drops - 1: Number of times the first peg is dropped during transport, assessing precision and control.
Moving Duration - 2: Similar to Moving Duration - 1 for the second peg, providing insight into consistency and endurance over multiple attempts.
First Peg Selection - 2: Time taken to select the first peg again, measuring sustained attention and readiness.
Transport Drops - 2: No. of drops during the second transport attempt, evaluating precision and control.
An increase in moving duration indicates a decline in eye-hand coordination speed.
Measured: Day 20 - 0 hours, Day 48 - 1, 3 & 5 hours ±15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on Sustained attention as assessed by Continuous Performance test (CPT) as compared to placebo and caffeine in acute stage.
This task is primarily designed to measure selective and sustained attention, with some capacity to assess impulsivity to a lesser degree. CPT measures sustained attention and response time. Sustained attention is measured by assessing how well participants can maintain their focus throughout the test. The response time is measured by calculating the average time it takes for a participant to respond to target stimuli. In the CPT, a decline in sustained attention is often reflected in increased response times and greater variability. This can occur as participants become fatigued or distracted over time, leading to slower and less consistent responses.Hence, a long response time may suggest cognitive slowing and/or impairment.
Measured: Day 0; Day 5; Day 10; Day 15 - 0, 1, 3 & 5 hours ±15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on Sustained attention as assessed by Continuous Performance test (CPT) as compared to placebo and caffeine in sub-acute stage.
This task is primarily designed to measure selective and sustained attention, with some capacity to assess impulsivity to a lesser degree. CPT measures sustained attention and response time. Sustained attention is measured by assessing how well participants can maintain their focus throughout the test. The response time is measured by calculating the average time it takes for a participant to respond to target stimuli. In the CPT, a decline in sustained attention is often reflected in increased response times and greater variability. This can occur as participants become fatigued or distracted over time, leading to slower and less consistent responses.Hence, a long response time may suggest cognitive slowing and/or impairment.
Measured: Day 20 - 0 hours, Day 48 - 1, 3 & 5 hours ±15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on Fatigue as assessed by the change in the Samn-Perelli fatigue scale (SPS) compared to placebo and caffeine in acute stage.
SPS is a uni-dimensional 7-point scale that was specifically developed to estimate fatigue in pilots. It is also a 7-point Likert-type scale of subjective fatigue ranging from 1 = "fully alert, wide awake, extremely peppy" to 7 = "completely exhausted, unable to function effectively, ready to drop.
Measured: Day 0; Day 5; Day 10; Day 15 - 0, 1, 3 & 5 hours ±15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on Fatigue as assessed by the change in the Samn-Perelli fatigue scale (SPS) compared to placebo and caffeine in sub-acute stage.
SPS is a uni-dimensional 7-point scale that was specifically developed to estimate fatigue in pilots. It is also a 7-point Likert-type scale of subjective fatigue ranging from 1 = "fully alert, wide awake, extremely peppy" to 7 = "completely exhausted, unable to function effectively, ready to drop.
Measured: Day 20 - 0 hours, Day 48 - 1, 3 & 5 hours ±15 minutes post IP
To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the Complete Blood Count - CBC
The CBC typically includes:
1. WBC total and differential count (Reference range: 4 - 10 10^3/microlitres)-
2. erythrogram (RBC count (Reference range: 4.5 - 5.5 10^6/microlitres), determination of hemoglobin (Hb) (Reference range: 12.0 - 17.0 g/dL) and hematocrit (Reference range: 40 - 50 %), and indices calculation (mean corpuscular volume (MCV) (Reference range: 83-101 fL), mean corpuscular hemoglobin (MCH) (Reference range: 27 - 32 pg), mean corpuscular hemoglobin concentration (MCHC) (Reference range: 31.5 - 34.5 g/dL), and red cell distribution width (RDW) (Reference range: 11.6 - 14.0 %) and;
3. platelet count (Reference range: 7.4 - 11.4 fL) indices calculation
Measured: Screening and Day 48
To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the Liver Function Tests (LFT)
The liver function tests (LFT) typically include alanine transaminase (ALT) (Reference range: 9-72 IU/L) and aspartate transaminase (AST) (Reference range: 14-59 IU/L), alkaline phosphatase (ALP) (Reference range: 38-126 U/L). These tests aid in identifying areas of liver damage and, based on the elevation pattern, contribute to forming a differential diagnosis.
Measured: Screening and Day 48
To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the Kidney Function Tests (KFT)
The kidney function tests (KFT) typically include serum creatinine (Reference range: 0.5 - 1.4 mg/dL) and blood urea nitrogen (BUN) (Reference range: 7-23 mg/dL). These tests help to evaluate renal function and detect the presence of kidney disease.
Measured: Screening and Day 48

Timeline

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

10 Oct 202421 Mar 2025

First posted19 Aug 2024
Study start10 Oct 2024
Primary completion21 Mar 2025
Study completion21 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for FatigueStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Acute stage: Randomized, double-blind, placebo-controlled, single-dose, 4-way, cross-over, study Sub-Acute Stage: Randomized, double-blind, placebo-controlled, 4 arms, parallel study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06560008
Sponsor's protocol ID: EB/240403/ENXTRA/CSF
Status last verified: Jun 2025
First submitted: 8 Aug 2024
Last updated: 18 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of EnXtra® and EnXtra® + Caffeine on Mental Alertness and Fatigue in Healthy Individuals
ClinicalTrials.gov ID: NCT06560008
Acronym / sponsor ID: EB/240403/ENXTRA/CSF
Conditions: Fatigue, Mental Alertness
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
Collaborators: Enovate Biolife Pvt Ltd
Study start: 10 Oct 2024 (actual)
Primary completion: 21 Mar 2025 (actual)
Study completion: 21 Mar 2025 (actual)
First posted: 19 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Acute stage: Randomized, double-blind, placebo-controlled, single-dose, 4-way, cross-over, study Sub-Acute Stage: Randomized, double-blind, placebo-controlled, 4 arms, parallel study

Arm	Type	Receives
EnXtra® (300 mg) + Placebo (300 mg)	Active comparator	Dietary Supplement: EnXtra® (300 mg) + Placebo (300 mg)Acute Stage: Two capsules to be taken after breakfast orally 1 (single dose) x 4 periods = 4 days Sub-acute Stage: Two capsules to be taken after breakfast orally once a day for 28 days
Caffeine (200 mg) + Placebo (300 mg)	Active comparator	Dietary Supplement: Caffeine (200 mg) + Placebo (300 mg)Acute Stage: Two capsules to be taken after breakfast orally 1 (single dose) x 4 periods = 4 days Sub-acute Stage: Two capsules to be taken after breakfast orally once a day for 28 days
EnXtra® (300 mg) + Caffeine (200 mg)	Active comparator	Dietary Supplement: EnXtra® (300 mg) + Caffeine (200 mg)Acute Stage: Two capsules to be taken after breakfast orally 1 (single dose) x 4 periods = 4 days Sub-acute Stage: Two capsules to be taken after breakfast orally once a day for 28 days
Placebo (MCC 300 mg) + Placebo (300 mg)	Placebo comparator	Dietary Supplement: Placebo (MCC 300 mg) + Placebo (300 mg)Acute Stage: Two capsules to be taken after breakfast orally 1 (single dose) x 4 periods = 4 days Sub-acute Stage: Two capsules to be taken after breakfast orally once a day for 28 days

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Males and females aged between 18 and 40 years.
Individuals who have night sleep of 8±1 hours.
Individuals with BMI ≥ 18 and ≤ 29.9 kg/meter square
Alertness score (Jin Fan's ANT) of 50±20 ms after 24 hours of caffeine abstinence.
Individuals habituated to have at least 2 cups of coffee in a day.

Key exclusion criteria (20 listed)

Individuals diagnosed with sleep disorders secondary to another health problem.
Individuals with a trait of excessive food cravings.
History of consumption of psychedelic drugs.
Individuals who are caffeine dependent i.e. having a history of more than 3 cups (≥200 ml) in a day.
Individuals taking energy/ cognitive/ sedative supplements and are unwilling to stop taking those supplements for the duration of the study period.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EnXtra® (300 mg) + Placebo (300 mg)Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)	Dietary supplement	EnXtra® (300 mg) + Placebo (300 mg)
Caffeine (200 mg) + Placebo (300 mg)Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)	Dietary supplement	Caffeine (200 mg) + Placebo (300 mg)
EnXtra® (300 mg) + Caffeine (200 mg)Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)	Dietary supplement	EnXtra® (300 mg) + Caffeine (200 mg)
Placebo (MCC 300 mg) + Placebo (300 mg)Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)	Dietary supplement	Placebo (MCC 300 mg) + Placebo (300 mg)

Primary outcome

To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage.
Time frame: Day 0 at 0, 1, 3 and 5 hours ± 15 minutes post IP
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks. Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears. Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up. Centre cue condition, A cue appears at the screen's center just before the target stimulus. Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction. Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage.
Time frame: Day 5 at 0, 1, 3 and 5 hours ± 15 minutes post IP
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks. Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears. Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up. Centre cue condition, A cue appears at the screen's center just before the target stimulus. Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction. Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage.
Time frame: Day 10 at 0, 1, 3 and 5 hours ± 15 minutes post IP
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks. Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears. Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up. Centre cue condition, A cue appears at the screen's center just before the target stimulus. Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction. Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage.
Time frame: Day 15 at 0, 1, 3 and 5 hours ± 15 minutes post IP
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks. Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears. Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up. Centre cue condition, A cue appears at the screen's center just before the target stimulus. Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction. Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Sub-acute stage.
Time frame: Day 20 at 0 hours post IP
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks. Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears. Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up. Centre cue condition, A cue appears at the screen's center just before the target stimulus. Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction. Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Sub-acute stage.
Time frame: Day 48 at 1, 3 and 5 hours ± 15 minutes post IP
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks. Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears. Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up. Centre cue condition, A cue appears at the screen's center just before the target stimulus. Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction. Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.

9 secondary outcomes

To determine the effect of EnXtra® and EnXtra® + Caffeine on Eye-hand coordination as assessed by Nine hole peg test (NHPT) as compared to placebo and caffeine in Acute stage.
Time frame: Day 0; Day 5; Day 10; Day 15 - 0, 1, 3 & 5 hours ±15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on Eye-hand coordination as assessed by Nine hole peg test (NHPT) as compared to placebo and caffeine in Sub-acute stage.
Time frame: Day 20 - 0 hours, Day 48 - 1, 3 & 5 hours ±15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on Sustained attention as assessed by Continuous Performance test (CPT) as compared to placebo and caffeine in acute stage.
Time frame: Day 0; Day 5; Day 10; Day 15 - 0, 1, 3 & 5 hours ±15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on Sustained attention as assessed by Continuous Performance test (CPT) as compared to placebo and caffeine in sub-acute stage.
Time frame: Day 20 - 0 hours, Day 48 - 1, 3 & 5 hours ±15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on Fatigue as assessed by the change in the Samn-Perelli fatigue scale (SPS) compared to placebo and caffeine in acute stage.
Time frame: Day 0; Day 5; Day 10; Day 15 - 0, 1, 3 & 5 hours ±15 minutes post IP
To determine the effect of EnXtra® and EnXtra® + Caffeine on Fatigue as assessed by the change in the Samn-Perelli fatigue scale (SPS) compared to placebo and caffeine in sub-acute stage.
Time frame: Day 20 - 0 hours, Day 48 - 1, 3 & 5 hours ±15 minutes post IP
To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the Complete Blood Count - CBC
Time frame: Screening and Day 48
To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the Liver Function Tests (LFT)
Time frame: Screening and Day 48
To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the Kidney Function Tests (KFT)
Time frame: Screening and Day 48

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EnXtra® (300 mg) + Caffeine (200 mg) in people with Fatigue and Mental Alertness, run by Vedic Lifesciences Pvt. Ltd. at 3 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 9 inclusion and 20 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 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage. (time frame: Day 0 at 0, 1, 3 and 5 hours ± 15 minutes post IP). The study lists 6 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 NCT06560008.

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 18 Jun 2025.