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Mental FatigueALERMENNCT02816827

A Study to Evaluate Efficacy of IP on Alertness and Mental Fatigue

A study testing AG-01, AG-05 and AG-06 in people with Mental Fatigue, run by Vedic Lifesciences Pvt. Ltd. at 1 site 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

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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Mental Fatigue
What is being tested?
AG-01, AG-05 and AG-06
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteIndia
Study dates
Mar 2016to Aug 2016
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

  • Healthy Male and female computer literate subjects (able to use computers/related technology efficiently)in the age group of 18-40 years of age.
  • Subject should be moderate caffeine consumers.
  • All subjects should be predominantly right handed.
  • Subject has a body mass index (BMI) of ≥18.5 and <25.00 kg/m2.
  • Subjects with Generalized Anxiety Disorder Screener (GAD-7) score ≤ 7.
  • Subjects screened for depression by Patient Health Questionnaire-9 (PHQ-9) with score ≤ 14.
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  • Subjects having score of at least 50 ± 20 two out of three readings on Jin Fan's Attention Network Test (ANT) version 1.3.0 after 24 hrs of caffeine abstinence performed at an interval of 30-60 mins each.
  • Subject is willing to refrain from consuming caffeine and caffeine-containing products 24 hrs prior to enrollment and during the study prior to all visit to site.
  • Subject agrees to refrain from using turmeric, ginger, cardamom, lemon grass , galangal, beetle leave, and beetle nuts containing products like thai food, tea masala, thai sauces, mouth freshener, paan, etc on the day prior to clinic visit.
  • Subject is willing to refrain from vigorous physical activity 12 hrs prior to clinic visit.
  • Subject should complete at least 7-8 hours of sleep on the night prior the clinic visit.
  • Subject is a non-smoker.
  • Female subjects currently in their menstrual period can be included only after the last day of menstrual flow.
  • Female Subjects consuming oral contraceptives can be included in study after a washout period of 7 days and are willing to stop its use during the study and opt for barrier contraceptive method.
  • Subject understands the study procedures and signed informed consent form to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Who cannot join

  • Subjects unable to abstain from caffeine containing products for 24 hrs.
  • Subjects suffering from primary or secondary insomnia with/ without active treatment.
  • Subjects with Generalized Anxiety Disorder Screener (GAD-7) score > 7.
  • Subjects with Personal health Questionnaire Score > 14.
  • Subjects suffering from type II Diabetes Mellitus.
  • Subject having health conditions that would prevent him/her from fulfilling the study requirements as judged by the investigator on the basis of medical history and routine laboratory test results.
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  • Subject has uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the average blood pressure measured at screening as well as randomization.
  • Subject has a history or presence of clinically significant cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorders that, in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
  • Subject has a history, in the judgment of the investigator, of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
  • Subject has a history or presence of oncological disorders.
  • Pregnant/ planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period.
  • Use of any psychotropic medication within four weeks of screening and throughout the study.
  • Use of antibiotics or signs of active systemic infection. Treatment visits will be rescheduled to allow the subject to wash off of the antibiotic for at least five days prior to any test visit.
  • Subject has had exposure to any non-registered drug product within 30 days prior to the screening visit.
  • Use of any other dietary supplements or herbal products.
  • Recent history of (within 12 months of screening visit 1) or strong potential for alcohol or substance abuse.
  • Subject has a known allergy or sensitivity to herbal product(s).

Trial locations and contacts

1 site in 1 country.

India1 site

  • Vedic Lifesciences

    Mumbai, Maharashtra, 400073

Other trials in India

About this study

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

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.

Read the 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.

Conditions
Mental Fatigue
Being tested
AG-01, AG-05, AG-06, AG-07
Medical subject headings
Mental Fatigue

What participants receive

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

  • AG-01Dietary supplement

    Product to increase mental alertness

  • AG-05Dietary supplement

    Product to increase mental alertness

  • AG-06Dietary supplement

    Product to increase mental alertness

  • AG-07Dietary supplement

    Product to increase mental alertness

Study groups in NCT02816827
Study groupRoleWhat they receive
E-AG-01Experimental550 mg of 2 capsules having AG-01 and AG-07 will be administered orally twice daily for one day.
Receives: Dietary Supplement: AG-01; Dietary Supplement: AG-07
E-AG-02Experimental550 mg of 2 capsules having AG-05 and AG-06 will be administered orally twice daily for one day.
Receives: Dietary Supplement: AG-05; Dietary Supplement: AG-06
E-AG-03Experimental550 mg of 2 capsules having AG-01 and AG-05 will be administered orally twice daily for one day.
Receives: Dietary Supplement: AG-01; Dietary Supplement: AG-05
E-AG-04Experimental550 mg of 2 capsules having AG-06 and AG-07 will be administered orally twice daily for one day.
Receives: Dietary Supplement: AG-06; Dietary Supplement: AG-07

What is being measured

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

  1. Alertness

    To assess the effect on mental alertness by Attention network test after ingestion of single dose of investigational product.

    Measured: Five hours

Timeline

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

  1. First posted29 Jun 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02816827
Sponsor's protocol ID
EB/160105/ER/AG
Acronym
ALERMEN
Status last verified
Aug 2016
First submitted
3 Mar 2016
Last updated
9 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Brunye TT, Mahoney CR, Lieberman HR, Taylor HA. Caffeine modulates attention network function. Brain Cogn. 2010 Mar;72(2):181-8. doi: 10.1016/j.bandc.2009.07.013. Epub 2009 Sep 5.

    PubMed 19733954

Questions about this trial

What is this clinical trial studying?

A study testing AG-01, AG-05 and AG-06 in people with Mental Fatigue, run by Vedic Lifesciences Pvt. Ltd. at 1 site 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 15 inclusion and 17 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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Alertness (time frame: Five hours). 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 NCT02816827, which also lists 1 linked publication.

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 9 Sep 2016.

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