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CTRI Number  CTRI/2018/07/014752 [Registered on: 05/07/2018] Trial Registered Prospectively
Last Modified On: 04/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Cluster Randomized Trial 
Public Title of Study   To know the awareness level of health care among tribal people and to know the traditional method , home remedies followed by them 
Scientific Title of Study   Health seeking behaviour among selected tribal population in TamilNadu 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr B MUTHU KARTHIKEYAN 
Designation  PG Scholar 
Affiliation  NATIONAL INSTITUTE OF SIDDHA 
Address  Department of Noi Naadal, National Institute of Siddha, Tambaram Sanatorium.

Chennai
TAMIL NADU
600047
India 
Phone  8903441419  
Fax    
Email  b.m.k.keyan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr G J CHRISTIAN 
Designation  Associated Professor 
Affiliation  NATIONAL INSTITUTE OF SIDDHA 
Address  Department of Noi Naadal, National Institute of Siddha, Tambaram Sanatorium.

Chennai
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr B MUTHU KARTHIKEYAN 
Designation  PG Scholar 
Affiliation  NATIONAL INSTITUTE OF SIDDHA 
Address  Department of Noi Naadal, National Institute of Siddha, Tambaram Sanatorium.

Chennai
TAMIL NADU
600047
India 
Phone  8903441419  
Fax    
Email  b.m.k.keyan@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  NATIONAL INSTITUTE OF SIDDHA 
Address  AYOTHIDOSS PANDITHAR HOSPITAL, NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI - 47 
Type of Sponsor  Research institution and hospital 
 
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 B MUTHU KARTHIKEYAN  KOTHIMANGALAM VILLAGE  kothimangalam colony, puliyur, thirukazhukundram, kancheepuram - district
Kancheepuram
TAMIL NADU 
8903441419

b.m.k.keyan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  All tribal people in kothimangalam village 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  cover all families. 
 
ExclusionCriteria 
Details  nil 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
after that we will know the awareness level of the healh care on tribal people and home remedies used by tribal people for the acute health problems  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   09/07/2018 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
It is a cluster randomized, cross sectional, observational study. To know the awareness level of health care among tribal people in kothimangalam village. In kothimangalam village have two part of tribal area namely - kothimangalam, puliyur. Here given sample size 138 is total number of tribal family living kothimangalam village. This study conducted on those people and the outcome of study will be assessed by basic questionnaries about health care.
 
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