Cognitive Change
Conditions
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.
Interventions
DRUGOcimum Sanctum
Active capsules containing leaves of organically prepared ocimum sanctum
DRUGPlacebo
Placebo capsules of look alike inert substance for control
Sponsors
Composite Interceptive Med Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Concealment of allocation and blinding of active versus placebo and blinded assessment
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
India
Outcome results
None listed