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Tulsi and its effects on facilitative cognitive enhancement through lowering levels of stress and anxiety. A randomised placebo-controlled clinical trial.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tulsi active | Experimental |
| |
| Tulsi placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocimum Sanctum | Drug | Active capsules containing leaves of organically prepared ocimum sanctum |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who meet the following criteria
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| Name | Affiliation | Role |
|---|---|---|
| Alben Sigamani, MD | Narayana Hrudayalaya Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital | Bangalore | Karnataka | 560099 | India |
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| ID | Term |
|---|---|
| C000713370 | holy basil leaf extract |
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Concealment of allocation and blinding of active versus placebo and blinded assessment
| Placebo | Drug | Placebo capsules of look alike inert substance for control |
|
It is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder (GAD) |
| 6 weeks |