| CTRI Number |
CTRI/2024/04/065248 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effect of coffee/tea consumption and its association with stress levels in age 20 - 40 old population in Mumbai |
|
Scientific Title of Study
|
Comparative study on excessive Tea / Coffee consumption on stress levels of college going students and working adults age (20-40 years) in Mumbai |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farzeen Akeel Zariwala |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr BMN College of Home Science 338,Rafi Ahmed Kidwai Rd, Matunga East Mumbai, Maharashtra 400019
Dr BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9769037966 |
| Fax |
|
| Email |
farzeenzariwala26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuradha Shekar |
| Designation |
Retired Associate Professor |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East Mumbai
Dr BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha237@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Farzeen Akeel Zariwala |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai
Dr BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Maharashtra
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9769037966 |
| Fax |
|
| Email |
farzeenzariwala26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BMN College of Home Science |
|
|
Primary Sponsor
|
| Name |
Farzeen Akeel Zariwala |
| Address |
Dr BMN College of Home Science 338, Rafi Ahmed Kidwai Road Matunga East, Mumbai Maharashtra 400019 |
| Type of Sponsor |
Other [Dr BMN College Department of clinical nutrition and dietetics ] |
|
|
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 |
| Farzeen Zariwala |
Dr. BMN College of Home Science |
Department of Postgraduate Studies in Clinical Nutrition and Dietetics, Matunga
Mumbai
MAHARASHTRA |
9769037966
farzeenzariwala26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 20-40 years.
2. College going students and working individuals |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is no significant difference between stress and anxiety with intake of consumption of tea/ coffee |
2 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim : To compare the effect of coffee/ tea consumption and its association with stress levels in age 20-40 years old population in Mumbai
Objective: 1. To quantify the patterns and levels of caffeine consumption among young adults in Mumbai.
2. To examine the prevalence of stress and anxiety using the scale : C-FFQ, Perceived stress scale.
3. To conduct a comparative study between college going student and working adults. |