| CTRI Number |
CTRI/2022/09/045674 [Registered on: 19/09/2022] Trial Registered Prospectively |
| Last Modified On: |
13/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Jadugoda Mines on local residents in nearby areas |
|
Scientific Title of Study
|
Environmental effect of Jadugoda mines complex over its adjacent villages and its clinico-epidemiological correlates |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isha Vasudev |
| Designation |
MBBS Student |
| Affiliation |
Manipal Tata Medical College |
| Address |
2nd year MBBS,room no F65,Girls Hostel Manipal Tata Medical College Kadani Road Bardih Jmashedpur
Purbi Singhbhum
JHARKHAND
831017
India |
| Phone |
9003256136 |
| Fax |
|
| Email |
isha.e@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashim Mishra |
| Designation |
Professor Forensic Medicine |
| Affiliation |
Manipal Tata Medical College |
| Address |
Department of Forensic Medicine and Toxicology, Room No.3 3rd Floor, New Academic Block, Manipal Tata Medical College Kadani Road Bardih Jamshedpur
Purbi Singhbhum
JHARKHAND
831017
India |
| Phone |
8391934762 |
| Fax |
|
| Email |
ashim.mishra@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashim Mishra |
| Designation |
Professor Forensic Medicine |
| Affiliation |
Manipal Tata Medical College |
| Address |
Department of Forensic Medicine and Toxicology room no 3 3rd Floor New Academic Block Manipal Tata Medical College Kadani Road Bardih Jamshedpur
Purbi Singhbhum
JHARKHAND
831017
India |
| Phone |
8391934762 |
| Fax |
|
| Email |
ashim.mishra@manipal.edu |
|
|
Source of Monetary or Material Support
|
| ICMR Short Term Student Grant 2022-01196 |
|
|
Primary Sponsor
|
| Name |
ICMRSTS |
| Address |
V. Ramalingaswami Bhawa
Post Box No 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Ashim Mishra |
Kareidunguri |
Talsa village kareidungri GP
District East Singhbhum
Purbi Singhbhum
JHARKHAND |
8391934762
ashim.mishra@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Ethics Commitee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Q00-Q99 |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
The people who are permanent residents of the area |
|
| ExclusionCriteria |
| Details |
The migrants who are temporary inhabitants and the person who refuse to give consent |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of congenital abnormalities |
Since it is a cross sectional study the participants shall be assessed for congenital abnormalities by using pre-designed structured questionnaire and appropriate screening tools at base level and there shall be no follow up visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The prevalence of Tuberculosis, Cancer mental retardation shall be taken into consideration |
It is cross sectional study and only the participants data collected at base level and there shall be no follow up visit |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
20/09/2022 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
NA |