| CTRI Number |
CTRI/2018/02/012029 [Registered on: 21/02/2018] Trial Registered Prospectively |
| Last Modified On: |
10/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Occupational Hazards on the Lung, Eye and Ear Health of Traffic constables of Nashik |
|
Scientific Title of Study
|
Study 0f Traffic Hassles And Environmental Hazards on the Pulmonary, Eye AND Ear Health Of Traffic Police in Nashik. |
| Trial Acronym |
TOPEE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bandopadhayay Anirban |
| Designation |
Consultant Chest Specialist |
| Affiliation |
Lele Ent Hospital |
| Address |
Surabhi Hospital,208, Sai Square, Mumbai Naka, Nashik
Tilakwadi, Nashik
Nashik
MAHARASHTRA
422001
India |
| Phone |
9890712199 |
| Fax |
|
| Email |
anbandu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bandopadhayay Anirban |
| Designation |
Consultant Chest Specialist |
| Affiliation |
Lele Ent Hospital |
| Address |
Surabhi Hospital, 208, Sai Square, Mumbai Naka, Nashik
Tilakwadi, Nashik
Nashik
MAHARASHTRA
422001
India |
| Phone |
9890712199 |
| Fax |
|
| Email |
anbandu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bandopadhayay Anirban |
| Designation |
CONSULTANT CHEST SPL |
| Affiliation |
Lele Ent Hospital |
| Address |
Surabhi Hospital, 208, Sai Square, Mumbai Naka, Nashik
Tilakwadi, Nashik
Nashik
MAHARASHTRA
422001
India |
| Phone |
9890712199 |
| Fax |
|
| Email |
anbandu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Surabhi Hospital, 208, Sai Square, Mumbai Naka, Nashik
16 bedded Chest And Eye Hospital |
|
|
Primary Sponsor
|
| Name |
Surabhi Hospital |
| Address |
208, Sai Square, Mumbai Naka, Nashik |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Rotary Club |
Canada Corner Nashik |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lele Pushkar |
Lele Ent Hospital |
Tilakwadi, Nashik
Nashik
MAHARASHTRA |
9822030871
pushkarlele@gmail.com |
| DR BANDOPADHYAY Anirban |
Surabhi Hospital |
Surabhi Hospital, 208, Sai Square, Mumbai Naka, Nashik
Nashik
MAHARASHTRA |
9890712199
anbandu@gmail.com |
| Dr Bandopadhyay Shweta |
Surabhi Hospital |
208, Sai Square, Mumbai Naka, Nashik
Nashik
MAHARASHTRA |
09890093712
anbandu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHATABDI HOSPITAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
62.00 Year(s) |
| Gender |
Both |
| Details |
Traffic police from joining age to retirement age |
|
| ExclusionCriteria |
| Details |
Traffic police after retirement age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalance of
1.Obstructive lung disease
2.Lung infections
3.Sleep Disorders
4.Diabetes
5.Hypertension
6. IHD
7. Eye Diseases
8. Hearing Loss
in Traffic Police |
On day of examination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Screening Of Lung Cancer |
On day of examination |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
Final Enrollment numbers achieved (Total)= "196"
Final Enrollment numbers achieved (India)="196" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
21/02/2018 |
| Date of Study Completion (India) |
30/04/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
TOPEE study is to detect ill effects of traffic hassles and environmental hazards on the health of traffic police of nashik and help them modify their life style and inform them interventions for eye ear and chest diseases in them
|