Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety
Consumption of Tulsi and Its Effects on Neurocognition, Stress and Anxiety: A Randomised Controlled Clinical Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
Tulsi and its effects on facilitative cognitive enhancement through lowering levels of stress and anxiety. A randomised placebo-controlled clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Start
First participant enrolled
December 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedSeptember 17, 2018
September 1, 2018
4 months
June 2, 2017
September 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
To measure change in cortisol level from saliva in 6 weeks
6 weeks
To measure change in Generalized Anxiety Disorder 7-Item Scale in 6 weeks
6 weeks
Study Arms (2)
Tulsi active
EXPERIMENTALTulsi placebo
PLACEBO COMPARATORInterventions
Active capsules containing leaves of organically prepared ocimum sanctum
Eligibility Criteria
You may qualify if:
- Subjects between the ages of 18 and 50 years, providing written informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital
Bangalore, Karnataka, 560099, India
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Alben Sigamani, MD
Narayana Hrudayalaya Limited
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Concealment of allocation and blinding of active versus placebo and blinded assessment
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2017
First Posted
June 14, 2017
Study Start
December 14, 2017
Primary Completion
March 30, 2018
Study Completion
March 31, 2018
Last Updated
September 17, 2018
Record last verified: 2018-09