| CTRI Number |
CTRI/2018/05/013631 [Registered on: 03/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of petrol on petrol pump workers |
|
Scientific Title of Study
|
Evaluation of various cardio-respiratory parameters in petrol pump attendants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tufayl Ahmed Shekha |
| Designation |
MBBS |
| Affiliation |
Dr. Vasantrao Pawar Medical College Hospital and Research Center |
| Address |
Central Research Laboratory, Dr. Vasantrao Pawar Medical College,Adgaon
Nashik
MAHARASHTRA
422003
India |
| Phone |
8806423889 |
| Fax |
|
| Email |
ahmed.tufayl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tufayl Ahmed Shekha |
| Designation |
MBBS |
| Affiliation |
Dr. Vasantrao Pawar Medical College Hospital and Research Center |
| Address |
Central Research Laboratory, Dr. Vasantrao Pawar Medical College,Adgaon
MAHARASHTRA
422003
India |
| Phone |
8806423889 |
| Fax |
|
| Email |
ahmed.tufayl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tufayl Ahmed Shekha |
| Designation |
MBBS |
| Affiliation |
Dr. Vasantrao Pawar Medical College Hospital and Research Center |
| Address |
Central Research Laboratory, Dr. Vasantrao Pawar Medical College,Adgaon
MAHARASHTRA
422003
India |
| Phone |
8806423889 |
| Fax |
|
| Email |
ahmed.tufayl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Vasantrao Pawar Medical College Hospital and Research Center Nashik |
|
|
Primary Sponsor
|
| Name |
Dr Vasantrao Pawar Medical College |
| Address |
Vasant Dada Nagar, Adgaon ,Nashik |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Tufayl Ahmed Shekha |
Petrol Pumps Randomly Selected in Nashik City |
Nashik
Nashik
MAHARASHTRA |
8806423889
ahmed.tufayl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr. Vasantrao Pawar Medical College Hospital and Research Center, Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening for abnormal/wide varied heart rate, blood pressure ,spo2 , respiratory rate , cardiac output and hear rate variability in apparently healthy petrol pump workers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Age group of 20 to 50.
Subjects who have given written informed
consent. |
|
| ExclusionCriteria |
| Details |
Cigarette or beedi smokers.Subjects with history of any acute illness.Subjects with disorder affecting Autonomic
Nervous System.Patient with known hypertension, asthma,
COPD or on any medications. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cardiac Output, Heart Rate , Heart Rate Variability , Blood Pressure, Respiratory rate , SpO2 |
22/09/2016 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Establishing realtion between , if any : Cardiac Output, Heart Rate , Heart Rate Variability , Blood Pressure, Respiratory rate , SpO2 and time since employed at petrol pump |
22/09/2016 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/04/2016 |
| Date of Study Completion (India) |
22/09/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not done yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The attendants at petrol pump are constantly exposed to petroleum products. Morever they dont wear any safety or protection gear. This study was carried out to know effect of petroleum products on cardiac output , heart rate variability , respiratory rate, blood pressure, spo2 , heart rate of Petrol punp workers |