Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety

Not Applicable

Completed

• Conditions: Cognitive Change
• Interventions: Drug: Placebo; Drug: Ocimum Sanctum

• Registration Number: NCT03184909
• Lead Sponsor: Composite Interceptive Med Science

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.

Study Timeline

• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-11
• Study First Posted: 2017-06-14
• Study Start: 2017-12-14
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-14
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tulsi placebo	Placebo	-
Tulsi active	Ocimum Sanctum	-

Primary Outcome Measures

Name	Time	Method
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	6 weeks	The Cambridge Neuropsychological Test Automated Battery (CANTAB) is a digital tool to measure the cognitive function.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital; 🇮🇳 Bangalore, Karnataka, India