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Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety

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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

Tracking Information
First Submitted Date  ICMJE June 2, 2017
First Posted Date  ICMJE June 14, 2017
Last Update Posted Date September 17, 2018
Actual Study Start Date  ICMJE December 14, 2017
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03184909 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2017)
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety
Official Title  ICMJE Consumption of Tulsi and Its Effects on Neurocognition, Stress and Anxiety: A Randomised Controlled Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Cognitive Change
Intervention  ICMJE
  • Drug: Ocimum Sanctum
    Active capsules containing leaves of organically prepared ocimum sanctum
  • Drug: Placebo
    Placebo capsules of look alike inert substance for control
Study Arms  ICMJE
  • Experimental: Tulsi active
    Intervention: Drug: Ocimum Sanctum
  • Placebo Comparator: Tulsi placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 31, 2018
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03184909
Other Study ID Numbers  ICMJE OI-006-2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Composite Interceptive Med Science
Study Sponsor  ICMJE Composite Interceptive Med Science
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alben Sigamani, MD Narayana Hrudayalaya Limited
PRS Account Composite Interceptive Med Science
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP