| CTRI Number |
CTRI/2024/07/070825 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Public survey regarding knowledge of electronic cigarettes in individuals between 18 to 30 years of age in a city of western Maharashtra |
|
Scientific Title of Study
|
Awareness of knowledge about e-cigarettes in individuals between 18 to 30 years of age in a city of western Maharashtra: A Survey |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaju Vaishnavi |
| Designation |
PG student |
| Affiliation |
Ug and pg colleges under Deccan education society |
| Address |
Ground floor Cardiovascular and Respiratory department D.E society of brijlal Jindal college of physiotherapy Fergusson college campus fc road shivajinagar pune-411004
Pune
MAHARASHTRA
411004
India |
| Phone |
8888577884 |
| Fax |
|
| Email |
jajuvaishnavi22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreya Rahul Dhake PT |
| Designation |
Associate professor and HOD |
| Affiliation |
D.E society of brijlal Jindal college of physiotherapy. |
| Address |
Ground floor Cardiovascular and Respiratory department of D.E society of brijlal Jindal college of physiotherapy Fergusson college campus fc road shivajinagar pune-411004
Pune
MAHARASHTRA
411004
India |
| Phone |
9892252731 |
| Fax |
|
| Email |
shreya.dhake@despune.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya Rahul Dhake PT |
| Designation |
Associate professor and HOD |
| Affiliation |
D.E society of brijlal Jindal college of physiotherapy. |
| Address |
Ground floor Cardiovascular and Respiratory department of D.E society of brijlal Jindal college of physiotherapy Fergusson college campus fc road shivajinagar pune-411004
Pune
MAHARASHTRA
411004
India |
| Phone |
9892252731 |
| Fax |
|
| Email |
shreya.dhake@despune.org |
|
|
Source of Monetary or Material Support
|
| General population with age group of 18 to 30 year of age. |
| Jaju vaishnavi
D.E society of brijlal Jindal college of physiotherapy Fergusson college campus road shivajinagar pune -411004 |
|
|
Primary Sponsor
|
| Name |
Jaju vaishnavi |
| Address |
D.E society of brijlal Jindal college of physiotherapy Fergusson college campus fc road shivajinagar pune-411004 |
| Type of Sponsor |
Other [self] |
|
|
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 Jaju Vaishnavi |
Deccan Education Society of Brijlal Jindal College Of Physiotheraphy |
Ground floor Cardiovascular and Respiratory department of D.E society of brijlal Jindal college of physiotherapy Fergusson college campus fc road shivajinagar pune-411004
Pune
MAHARASHTRA |
8888577884
Jajuvaishnavi22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, D.E societys brijlal jindal college of physiotherapy,pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
age group 18-30 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL
|
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Users between ages of 18-30 years old.
2.English spoken population. |
|
| ExclusionCriteria |
| Details |
1.More than 30 years old individual.
2.Mentally unstable and un cooperative individuals. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Questionnaire of Awareness OF Knowledge About E-Cigarettes Among individuals Between 18 and 30 Years of Age in a city Of Western Maharashtra |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="233"
Sample Size from India="233"
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)
|
01/08/2024 |
| 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="1"
Months="0"
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
|
In India studies related to ill effects of e-cigarettes are published, but there is dearth of literature with respect to knowledge of e-cigarettes among young individuals. Hence, my study aims to assess the knowledge about e-cigarettes in indiduals between age 18- 30 year in a city in western Maharashtra with a knowledge-based questionnaire. |