| CTRI Number |
CTRI/2018/10/016037 [Registered on: 15/10/2018] Trial Registered Prospectively |
| Last Modified On: |
08/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To understand how the migrant people live, conditions of their houses, and how they suffer from various illnesses because of these conditions |
|
Scientific Title of Study
|
Effects of living conditions of the migrant workers in Udupi on their health |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanghamitra Roy |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Faculty of Architecture,
First Floor,
Academic Block 2,
Manipal Institute of Technology,
Manipal Academy of Higher Education,
Manipal
Manipal.edu Building,
Manipal 576104,
Karnataka,
India
Udupi
KARNATAKA
576104
India |
| Phone |
9986448945 |
| Fax |
|
| Email |
sanghamitra.roy@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanghamitra Roy |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Faculty of Architecture,
First Floor,
Academic Block 2,
Manipal Institute of Technology,
Manipal Academy of Higher Education,
Manipal
Manipal.edu Building,
Manipal 576104,
Karnataka,
India
Udupi
KARNATAKA
576104
India |
| Phone |
9986448945 |
| Fax |
|
| Email |
sanghamitra.roy@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sanghamitra Roy |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Faculty of Architecture,
First Floor,
Academic Block 2,
Manipal Institute of Technology,
Manipal Academy of Higher Education,
Manipal
Manipal.edu Building,
Manipal 576104,
Karnataka,
India
Udupi
KARNATAKA
576104
India |
| Phone |
9986448945 |
| Fax |
|
| Email |
sanghamitra.roy@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education,
Manipal.edu Building,
Manipal 576104,
Udupi,
Karnataka,
India |
|
|
Primary Sponsor
|
| Name |
Sanghamitra Roy |
| Address |
Faculty of Architecture,
Academic Block 2, MIT,
Manipal Academy of Higher Education, |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sanghamitra Roy |
Manchi Kumeri |
Ward no. 20,
Manipal
Udupi
KARNATAKA |
9986448945
sanghamitra.roy@manipal.edu |
| Sanghamitra Roy |
Saralabettu |
Ward No. 14,
Manipal
Udupi
KARNATAKA |
9986448945
sanghamitra.roy@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health conditions faced by migrant workers such as respiratory problems, malaria, diarrhea, skin infections, etc. due to poor living conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Migrant workers and their family members
2. English and Kannada speaking population |
|
| ExclusionCriteria |
| Details |
Non-english and non-kannada speaking population |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of health issues due to their living conditions |
1 year 10 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Architectural and infrastructural design guidelines for betterment of living and health conditions |
1 year 10 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is to understand the effects of living conditions of migrant workers in Udupi on their health. The study will be conducted in migrant communities located in Saralabettu and Manchi Kumeri in Manipal, Udupi, Karnataka. 100 migrant workers and their family members, 18 to 59 years of age, both male and female, knowing English and/or Kannada will be recruited. It is an observational study using simple random sampling. Computer generated randomization will be used. Primary outcome is to identify the health issues due to their living conditions. Secondary outcome is to formulate architectural and infrastructural design guidelines for betterment of their living and health conditions |