Status:
COMPLETED
A Study to Evaluate the Effect of EnXtra® and EnXtra® + Caffeine on Mental Alertness and Fatigue in Healthy Individuals
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Collaborating Sponsors:
Enovate Biolife Pvt Ltd
Conditions:
Fatigue
Mental Alertness
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
October 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2025
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06560008
Start Date
October 10 2024
End Date
March 21 2025
Last Update
June 18 2025
Active Locations (3)
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1
New Manak Healcare Hospital
Navi Mumbai, Maharashtra, India, 400706
2
Gurukrupa Hospital
Thane, Maharashtra, India, 400601
3
Kalpana Hospital
Thane, Maharashtra, India, 400601