| CTRI Number |
CTRI/2024/04/065409 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Interplay of Indoor Biomass Combustion, Health Impacts, and Energy Dynamics in Rural Indian Homes |
|
Scientific Title of Study
|
A cross-sectional study looking at the effect of indoor biomass fuel on lung health and socio-economic parameters |
| 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 Raja Dhar |
| Designation |
Director and Head |
| Affiliation |
The Calcutta Medical Research Institute |
| Address |
Department of Pulmonology
1st Floor
The Calcutta Medical research Institute
7/2 Diamond Harbour Road
7/2 Diamond Harbour Road
Kolkata
WEST BENGAL
700027
India |
| Phone |
03340904090 |
| Fax |
|
| Email |
pulmoresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raja Dhar |
| Designation |
Director and Head |
| Affiliation |
The Calcutta Medical Research Institute |
| Address |
Department of Pulmonology
1st Floor
The Calcutta Medical Research Institute
Kolkata
7/2 Diamond Harbour Road
Kolkata
Kolkata
WEST BENGAL
Kolkata-700027
India |
| Phone |
03340904090 |
| Fax |
|
| Email |
pulmoresearch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raja Dhar |
| Designation |
Director and Head |
| Affiliation |
The Calcutta Medical Research Institute |
| Address |
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road
Kolkata
7/2 Diamond Harbour Road
Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
03340904090 |
| Fax |
|
| Email |
pulmoresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Prof Joyanto Routh |
| Address |
Department of Thematic Studies, Linköping University, Linköping SE58183, Sweden |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Raja Dhar Trustee You Breathe We Care |
P-171/1 CIT Scheme VII-M,Kolkata-700054 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raja Dhar |
The Calcutta Medical Research Institute |
Department of Pulmonology
1st floor
7/2 Diamond Harbour Road, Kolkata
Kolkata-700027
Kolkata
WEST BENGAL |
03340904090
pulmoresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, The Calcutta Medical Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J684||Chronic respiratory conditions dueto chemicals, gases, fumes and vapors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Men, women and children in the age range of 7 to 70 |
|
| ExclusionCriteria |
| Details |
Men, women and children age less than 7 and more than 70 yrs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Household surveys will establish the correlation between fuel usage, health, cooking practices and economic conditions based on the primary data collected
2. Establish the early diagnostic health effects associated with biomass burning. |
2-3 yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i.Development of low cost sensor loggers for real time measurement of household pollutants(PM,CO,CO2,VOCs,NO2 and NO)
ii. Quality of Life initiatives, focusing on early diagnosis and treatment for vulnerable pollutions exposed to biomass burning
iii.Contribute to Sustainable Development goal 3 (good health and well-being) and 7 (Affordable and clean energy) by advancing the agenda for clean energy,health and development
iv.Publications,workshops, communications, sharing and data management applies to all phases of the project |
i. 1-2 yr
ii. 2-3 yr
iii. 4 yr
iv. 1-4 yr |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Biofuels used in cooking and heating produce a toxic cocktail of particulate matter (PM), resulting in chronic lung complications. Only a few regions worldwide experience ambient PM levels as high as the Indo-Gangetic plains. On average, women and children breathe 75-100 µg/m3 of PM (WHO recommends <10 µg/m3), indicating the multifaceted healthcare, economic and environmental burden in rural households, where biofuel use prevails. And yet, regional ground-based PM data are sparse, there is poor awareness about air pollution, and clean energy initiatives are lagging. We hypothesize that biofuel combustion and PM exposure can be related to specific pollutant classes (triggers) and their synergistic interactions paving way for tracing early metabolomic signatures in plasma to diagnose the aging of lungs, asthma and COPD. Hence, we aim to 1) conduct socioeconomic and health surveys, and develop real-time indoor monitoring of PM using automated sensor networks, 2) analyze organic compounds and oxidative metals that trigger pulmonary stress, 3) identify novel biomarkers in plasma and combine the integrative transcriptomics, epidemiological and environmental chemical data. This interdisciplinary novel approach on PM characteristics and metabolomics will establish causality with PM to provide a holistic perception and tackle PM exposure to advance early diagnosis. These initiatives will further strategies to improve air quality and health (UN Sustainable Development Goals 3 and 7). |