Efficacy of Tulsi in the reduction of Stress and anxiety with improvement in mental functions
- Registration Number
- CTRI/2017/09/009826
- Lead Sponsor
- Organic India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
• Subjects between the ages of 18 and 50 years, providing written informed consent.
• All the potential study participant should have the recent complete clinical profile of biochemistry, renal function, liver function and hematological data within one year.
Any one of the following
• 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 within the last 12 months
• Any characteristic that makes the investigator uncomfortable to include the subject in the study.
• Pregnant, attempting to conceive, or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess a change in facilitative cognitive function from baseline in 6 weeks by comparing the results on cognitive tests Cantab® between active and placebo groupTimepoint: 6 weeks
- Secondary Outcome Measures
Name Time Method To measure change in Cohen Perceived Stress Scale in 6 weeksTimepoint: 6 weeks;To measure change in cortisol level from saliva in 6 weeksTimepoint: 6 weeks;To meaure change in The State-Trait Anxiety Inventory(STAI) in 6 weeksTimepoint: 6 weeks