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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
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