| CTRI Number |
CTRI/2018/01/011194 [Registered on: 08/01/2018] Trial Registered Prospectively |
| Last Modified On: |
18/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
QUALITATIVE AND QUANTITATIVE |
| Study Design |
Other |
|
Public Title of Study
|
awareness, attitude, knowledge, and meat consumption practices among tribal in koraput, Odisha |
|
Scientific Title of Study
|
A study on socio-demographic and behavioral aspects related to anthrax among the tribal population of Koraput, Odisha. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sipra makhija |
| Designation |
Masters in Public health student |
| Affiliation |
manipal university |
| Address |
Prasanna school of public health, 2nd floor,
old tapmi building, manipal university, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7975162315 |
| Fax |
|
| Email |
shipra.makhija37@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sumit kumar |
| Designation |
assistant professor |
| Affiliation |
Prasanna school of public health |
| Address |
Prasanna school of public health, 2nd floor,
old tapmi building, manipal university, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8867620088 |
| Fax |
|
| Email |
sumitsharma315@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sipra makhija |
| Designation |
Masters in Public health student |
| Affiliation |
manipal university |
| Address |
Prasanna school of public health, 2nd floor,
old tapmi building, manipal UNIVERSITY MANIPAL
C/O AG SHETTY, NEHRU NAGAR, BEHIND VALLEY FLATS, MANIPAL 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7975162315 |
| Fax |
|
| Email |
shipra.makhija37@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sipra makhija |
| Address |
Prasanna school of public health, 2nd floor,old tapmi building, manipal |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| sipra makhija |
COMMUNITY OF LUMTAPUT |
SIPRA MAKHIJA
Integrated disease surveillance unit, Koraput, odisa
Koraput
ORISSA |
7975162315
shipra.makhija37@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC KMC AND KH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals male/ female from the community |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
Those who are willing to give consent Males/ Females 18 to 58 year. |
|
| ExclusionCriteria |
| Details |
Those who are NOT willing to give consent Males/ Females 18 to 58 year. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Awareness, attitude, practices, knowledge regarding the disease.
2.Cultural factors, and its association with the occurrence of diseases |
January to march |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BEHAVIOURAL FACTORS AND SOCIO DEMOGRAPHIC FACTORS WHICH ARE CONTRIBUTING TO THE OUTBREAKS OF ANTHRAX |
JAN TO MARCH 2018 |
|
|
Target Sample Size
|
Total Sample Size="171"
Sample Size from India="171"
Final Enrollment numbers achieved (Total)= "171"
Final Enrollment numbers achieved (India)="170" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2018 |
| Date of Study Completion (India) |
16/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
the thesis will be submitted to the Prasanna school of public health. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
koraput districts have 14 blocks, among that lumaptaput block is the most endemic region for anthrax, frequent outbreaks are reported every year, the block has a tribal population of 25,340 (census2011), The study will be conducted in two phases, i.e. Phase 1 quantitative and phase 2 qualitative. Question regarding demographic, social, behaviour aspects will be included. |