Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety

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

Detailed Description
-----------------
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.

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

Conditions
-----------------
Cognitive Change

Intervention / Treatment
-----------------
* Drug: Ocimum Sanctum
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tulsi active<br> | Drug: Ocimum Sanctum<br>* Active capsules containing leaves of organically prepared ocimum sanctum<br>|
| Placebo Comparator: Tulsi placebo<br> | Drug: Placebo<br>* Placebo capsules of look alike inert substance for control<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The Cambridge Neuropsychological Test Automated Battery (CANTAB) is a digital tool to measure the cognitive function. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure change in cortisol level from saliva in 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 | 6 weeks | 
| To measure change in Generalized Anxiety Disorder 7-Item Scale in 6 weeks | It is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder (GAD) | 6 weeks |