An interventional study of Ocimum Sanctum and Placebo in Cognitive Change, sponsored by Composite Interceptive Med Science. Completed at 1 site in India. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-17.
Sponsored by Composite Interceptive Med Science · Not applicable, Interventional, and Supportive care
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.
Composite Interceptive Med Science is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Subjects who meet the following criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Ocimum Sanctum
Drug: Placebo
Active capsules containing leaves of organically prepared ocimum sanctum
Placebo capsules of look alike inert substance for control
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.
Time frame: 6 weeks
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
Time frame: 6 weeks
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)
Time frame: 6 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Mar 2018, 3 months.
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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Holy basil leaf extract
Composite Interceptive Med Science