| CTRI Number |
CTRI/2024/09/073240 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Respiratory Health of Urban Traffic Police in East Sikkim: A Cross-Sectional Study |
|
Scientific Title of Study
|
Status of Respiratory Health among Urban Traffic Police Personnel of East Sikkim : A Cross-Sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Tenzing Tseyang Bhutia (PT) |
| Designation |
Post graduation student |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Sikkim Manipal Institute of Medical Sciences, 5th mile Tadong, Gangtok, Sikkim Sikkim Manipal Institute of Medical Sciences, 5th mile Tadong, Gangtok, Sikkim East SIKKIM 737102 India |
| Phone |
8918026718 |
| Fax |
|
| Email |
tenzingtseyang3332@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Prabin Pradhan (PT) |
| Designation |
Lecturer |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Sikkim Manipal Institute of Medical Sciences, 5th mile Tadong, Gangtok, Sikkim Sikkim Manipal Institute of Medical Sciences, 5th mile Tadong, Gangtok, Sikkim East SIKKIM 737102 India |
| Phone |
7848985490 |
| Fax |
|
| Email |
prabin.p@smims.smu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr. Tenzing Tseyang Bhutia (PT) |
| Designation |
Post graduation student |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Sikkim Manipal Institute of Medical Sciences, 5th mile Tadong, Gangtok, Sikkim Sikkim Manipal Institute of Medical Sciences, 5th mile Tadong, Gangtok, Sikkim East SIKKIM 737102 India |
| Phone |
8918026718 |
| Fax |
|
| Email |
tenzingtseyang3332@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Referral Hospital, 5th mile Tadong, Gangtok, Sikkim, India 737102 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Tenzing Tseyang Bhutia PT |
Central Referral Hospital |
Central Referral Hospital, Department of Physiotherapy, 5th floor, 5th Mile Tadong, Gangtok, East Sikkim, Sikkim, India East SIKKIM |
8918026718
tenzingtseyang3332@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy human being |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
1. Traffic police personnel with more than 1 year working experience in traffic management
2. Age more than 20 and less than 58
3. All genders |
|
| ExclusionCriteria |
| Details |
1. Recent abdominal/thoracic surgery within a month
2. Traffic police personnel working at office
3. Unwilling to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
ATS-DLD questionnaire
Peak Flow Meter |
One time study (Cross-sectional study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="118" Sample Size from India="118"
Final Enrollment numbers achieved (Total)= "118"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2024 |
| Date of Study Completion (India) |
25/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/03/2024 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Lung India |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Air pollution is a critical global issue with severe consequences for human health and the environment. According to the World Health Organization (WHO), air pollution results in approximately 2.4 million deaths annually. By 2018, 91% of the global population lived in areas where air pollution levels exceeded safety thresholds, with 2020 recording six million deaths attributed to both indoor and outdoor air pollution. In India, cities such as Delhi, Mumbai, and Bengaluru face some of the highest health impacts from air pollution, which significantly affects respiratory health. Air pollutants are substances that can harm humans, animals, vegetation, or materials. The primary route of human exposure to these pollutants is through inhalation, though ingestion and skin contact can also contribute. Pollutants like particulate matter (PM), nitrogen dioxide (NO2), sulfur dioxide (SO2), and carbon monoxide (CO) can enter the bloodstream via the gastrointestinal and respiratory tracts, impacting various organs and leading to health problems. Short-term effects of air pollution include eye irritation, coughing, headaches, and fatigue, while long-term exposure can cause chronic respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD), cardiovascular disorders, and an increased risk of cancer. Specifically, PM2.5, with particles smaller than 2.5 micrometers, poses significant health risks as these particles can penetrate deep into the lungs and even enter the bloodstream. The impact of air pollution extends to various body systems: - Respiratory System: Pollutants can lead to chronic cough, wheezing, and exacerbation of conditions like asthma and COPD. Studies indicate that high levels of PM10 and NO2 exposure are linked to increased asthma risk and other respiratory issues.
- Cardiovascular System: Exposure to pollutants such as PM2.5 and NO2 is associated with progression in coronary artery disease, atherosclerosis, and hypertension, leading to potential heart disease.
- Endocrine System: Prolonged exposure to particulate matter and NO2 is linked to a higher risk of developing diabetes.
- Urinary System: Pollutants can affect kidney function, increasing the risk of chronic kidney disease and impairing glomerular filtration rate.
- Immune System: Increased air pollution exposure is associated with a higher risk of cancer, potentially due to defects in DNA repair mechanisms.
The pathophysiology of air pollution involves oxidative stress, where pollutants generate reactive oxygen and nitrogen species (ROS/RNS) that cause cellular damage, inflammation, and systemic effects throughout the body. Macrophages, part of the immune system, may release inflammatory markers, leading to further health issues. Traffic police personnel, who spend extensive periods managing road traffic in urban areas, are particularly at risk due to continuous exposure to vehicular emissions. This exposure contributes to a higher prevalence of respiratory symptoms like cough, phlegm, and rhinitis compared to the general population. Despite this, there is a lack of localized studies, particularly in areas like East Sikkim, to assess the specific impact on traffic police personnel. The proposed research aims to evaluate the respiratory health of urban traffic police personnel in East Sikkim using a cross-sectional study design. The study will utilize tools such as the ATS-DLD questionnaire to assess respiratory symptoms and a peak flow meter to measure peak expiratory flow rate (PEFR). This study will gather data on respiratory health status, analyze the impact of air pollution on traffic police, and provide insights into necessary preventive measures and interventions. |