| CTRI Number |
CTRI/2017/09/009826 [Registered on: 18/09/2017] Trial Registered Prospectively |
| Last Modified On: |
18/09/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Tulsi in the reduction of Stress and anxiety with improvement in mental functions |
|
Scientific Title of Study
|
Consumption of Tulsi and Its Effects on Neurocognition, Stress and Anxiety: A Randomised Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT03184909 |
ClinicalTrials.gov |
| OI-006-2017 Version 2.0 July 01 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alben Sigamani |
| Designation |
Principal Investigator |
| Affiliation |
Narayana Hrudayalaya Hospital |
| Address |
1st Floor, B Block, Room Number 32, Department of Clinical Research, Mazumdar Shaw Medical Centre, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
560099
India |
| Phone |
8884431444 |
| Fax |
|
| Email |
drsigamani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjaya Chauhan |
| Designation |
Clinical Research Associate |
| Affiliation |
Organic India |
| Address |
6th floor, B Block, Room No 32, Department of Clinical Research, Mazumdar Shaw Cancer Centre
Narayana Health City, Bommasandra Industrial Area
Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
560099
India |
| Phone |
9900248931 |
| Fax |
|
| Email |
drsanjayachauhan49@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sindhu N |
| Designation |
Co-Investigator |
| Affiliation |
Organic India |
| Address |
6th floor, B Block, Room No 32, Department of Clinical Research, Mazumdar Shaw Cancer Centre
Narayana Health City, Bommasandra Industrial Area
Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
560099
India |
| Phone |
9902643747 |
| Fax |
|
| Email |
reddysindhu993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Organic India Private Limited – R&D
8th Floor, A Block, Mazumdar Shaw Cancer Centre
Narayana Health City, Bommasandra Industrial Area
Bangalore 560099, Karnataka State, INDIA |
|
|
Primary Sponsor
|
| Name |
Organic India |
| Address |
Organic India Private Limited – R&D
8th Floor, A Block, Mazumdar Shaw Cancer Centre
Narayana Health City, Bommasandra Industrial Area
Bangalore 560099, Karnataka State, INDIA |
| Type of Sponsor |
Other [Herbal Supplement Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alben Sigamani |
Narayana Hrudayala Limited Mazumdar Shaw Medical Centre |
Department of Clinical Research, 6st Floor, B Block, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA Bangalore KARNATAKA
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
8884431444
drsigamani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress and Anxiety |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ocimum Sanctum |
Ocimum Sanctum or Holy Basil, commonly called Tulsi is a traditional Indian herb. Each tulsi capsule contains 300 mg of powder drug. Each participant has to take 2 capsules twice daily for 6 weeks. |
| Comparator Agent |
Placebo |
Placebo capsules of look alike inert substance for control....Each participant has to take 2 capsules twice daily for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
• 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. |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 group |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure change in cortisol level from saliva in 6 weeks |
6 weeks |
| To measure change in Cohen Perceived Stress Scale in 6 weeks |
6 weeks |
| To meaure change in The State-Trait Anxiety Inventory(STAI) in 6 weeks |
6 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2017 |
| Date of Study Completion (India) |
30/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The Project Office Operations Committee will appoint members to a Publication Committee. This committee will create guidelines for publications related the study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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.
|