Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety

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

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

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Drug: Ocimum Sanctum; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Composite Interceptive Med Science
• Investigators: Principal Investigator: Alben Sigamani, MD, Narayana Hrudayalaya Limited

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 11, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: OI-006-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No