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OpenTrials
Completed

NCT Number: NCT03184909

Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety

Tulsi and its effects on facilitative cognitive enhancement through lowering levels of stress and anxiety. A randomised placebo-controlled clinical trial.

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Key information

Conditions

Cognitive Change

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital

Bangalore, Karnataka, 560099, India

About this study

Ocimum Sanctum or Holy Basil, commonly called Tulsi is a traditional Indian herb. It is believed to bring about a facilitative enhancement of cognitive ability and lower stress levels in individuals. Stress and an inability to perform at a required level of cognition can induce anxiety. This study is looking at the effects of daily consuming Tulsi among a group of individuals who work in an environment that demands memory, attention and executive functioning.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects between the ages of 18 and 50 years, providing written informed consent.

Exclusion criteria

Subjects who meet the following criteria

  • Education level below 8th grade of schooling
  • Unable to read or understand English or having no working knowledge of English
  • Known history or neurological conditions that can affect cognition
  • Known history of drug abuse or potential for drug abuse, a regular consumer of alcohol or unwilling to withhold consumption of alcohol for the duration of the study.
  • A chronic smoker or consumer of other tobacco related products or is undergoing a rehabilitation program for alcohol and or tobacco consumption
  • Any history or psychiatric disorders - currently on treatment or treated in within the last 12 months
  • Any characteristic that makes the investigator uncomfortable to include the subject in the study.

Treatment and study plan

Ocimum Sanctum

Drug

Active capsules containing leaves of organically prepared ocimum sanctum

Placebo

Drug

Placebo capsules of look alike inert substance for control

Primary outcomes

  1. To assess a change in facilitative cognitive function from baseline in 6 weeks by comparing the results on cognitive tests measured by Cambridge Neuropsychological Test Automated Battery (Cantab®) between active and placebo group

    Time frame: 6 weeks

    The Cambridge Neuropsychological Test Automated Battery (CANTAB) is a digital tool to measure the cognitive function.

Secondary outcomes

  1. To measure change in cortisol level from saliva in 6 weeks

    Time frame: 6 weeks

    Salivary levels of cortisol correlates with work related stress levels. Our intention is to evaluate the effect of ocimum sanctum in lowering stress and measured as a change in the cortisol levels

  2. To measure change in Generalized Anxiety Disorder 7-Item Scale in 6 weeks

    Time frame: 6 weeks

    It is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder (GAD)

Sponsors and collaborators

Lead sponsor

Composite Interceptive Med Science

Industry

Registry information

Official study title

Consumption of Tulsi and Its Effects on Neurocognition, Stress and Anxiety: A Randomised Controlled Clinical Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2017
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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