Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-14 @ 6:19 AM
Study NCT ID:
NCT02816827
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2016-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Efficacy of IP on Alertness and Mental Fatigue
Sponsor:
Vedic Lifesciences Pvt. Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double Dummy, Double Blind, Placebo Controlled Cross Over Study to Evaluate Efficacy of Investigational Product E-AG-01/ E-AG02/ E-AG-03/ E-AG-04 on Alertness and Mental Fatigue
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALERMEN
Brief Summary:
The current study is design to asses the effect of E-AG-01/ E-AG-02/ E-AG-03 on mental alertness as compared to placebo.
Detailed Description:
Intake of caffeinated drinks is known to improve energy levels, alertness, and concentration levels. Caffeine is a stimulant of central nervous system and therefore is probably the most commonly used psychoactive substance in the world. Caffeine intake is preferred by many individuals because moderate amount of caffeine consumption postulates certain beneficial effects on nervous system as well as on general well-being, like increase in the level of alertness and diminution in exhaustion especially in low arousal circumstances (e.g. working at night), improvements in performance on vigilance tasks and simple tasks that require sustained response. Along with these virtues caffeine intake is associated with certain demerits also. High dose of caffeine that is more than 400 mg a day in healthy adults may be associated with adverse events such as psycho motor agitation, insomnia, headache, gastrointestinal complaints depending on several other lifestyle parameters.
Since caffeine intake is habitual, withdrawal of caffeine poses certain concerns on performance like its negative impact on mood levels following its withdrawal.
Hence there is always a need to find an alternative to caffeine which has the same attributes of caffeine but is not associated with its habit forming stance. In order to fulfill this unmet need Enovate Biolife has designed a novel natural caffeine free ingredient which postulates to enhance the mental alertness and combats mental fatigue similar as caffeine without causing adverse effects associated with caffeine.
Since caffeine intake is habitual, withdrawal of caffeine poses certain concerns on performance like its negative impact on mood levels following its withdrawal.
Hence there is always a need to find an alternative to caffeine which has the same attributes of caffeine but is not associated with its habit forming stance. In order to fulfill this unmet need Enovate Biolife has designed a novel natural caffeine free ingredient which postulates to enhance the mental alertness and combats mental fatigue similar as caffeine without causing adverse effects associated with caffeine.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: