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Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03184909
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cognitive Change Drug: Ocimum Sanctum Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Concealment of allocation and blinding of active versus placebo and blinded assessment
Primary Purpose: Supportive Care
Official Title: Consumption of Tulsi and Its Effects on Neurocognition, Stress and Anxiety: A Randomised Controlled Clinical Trial
Actual Study Start Date : December 14, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184909


Locations
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India
Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital
Bangalore, Karnataka, India, 560099
Sponsors and Collaborators
Composite Interceptive Med Science
Investigators
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Principal Investigator: Alben Sigamani, MD Narayana Hrudayalaya Limited
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Responsible Party: Composite Interceptive Med Science
ClinicalTrials.gov Identifier: NCT03184909    
Other Study ID Numbers: OI-006-2017
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No