Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184909
• Other study ID #: OI-006-2017
• Status: Completed
• Phase: N/A
• Start date: December 14, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: September 2018
• Source: Organic India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change

Intervention

Drug:
• Ocimum Sanctum
Active capsules containing leaves of organically prepared ocimum sanctum
• Placebo
Placebo capsules of look alike inert substance for control

Locations

Country	Name	City	State
India	Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Organic India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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