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CTRI Number  CTRI/2024/12/078096 [Registered on: 13/12/2024] Trial Registered Prospectively
Last Modified On: 10/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Diagnostic test evaluation 
Study Design  Other 
Public Title of Study   Empowerment of Community workers in Resource -poor tribal area by training them to identify common skin problems using a diagnostic flowchart and flash cards I 
Scientific Title of Study   Empowerment of Community Workers in using a newly developed Diagnostic algorithm for Early Detection of Dermatological Problems ni aResource -poor Tribal Seting of Agasthyamala Biosphere Reserve forest area of Thiruvananthapuram district of Kerala." 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Simi S M 
Designation  Professor 
Affiliation  Sree Gokulam Medical College 
Address  Professor, Dept of Dermatology, Sree Gokulam Medical College, Venjaramoodu
Professor, Dept of Dermatology, Sree Gokulam Medical College, Venjaramoodu
Thiruvananthapuram
KERALA
695607
India 
Phone  09745620025  
Fax    
Email  drsimism@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Simi S M 
Designation  Professor 
Affiliation  Sree Gokulam Medical College 
Address  Professor, Dept of Dermatology, Sree Gokulam Medical College, Venjaramoodu
Professor, Dept of Dermatology, Sree Gokulam Medical College, Venjaramoodu
Thiruvananthapuram
KERALA
695607
India 
Phone  09745620025  
Fax    
Email  drsimism@gmail.com  
 
Details of Contact Person
Public Query  
Name  Simi S M 
Designation  Professor 
Affiliation  Sree Gokulam Medical College 
Address  Professor, Dept of Dermatology, Sree Gokulam Medical College, Venjaramoodu
Professor, Dept of Dermatology, Sree Gokulam Medical College, Venjaramoodu
Thiruvananthapuram
KERALA
695607
India 
Phone  09745620025  
Fax    
Email  drsimism@gmail.com  
 
Source of Monetary or Material Support  
Sree Gokulam Medical College & Research Foundation, Venjaramoodu, Thiruvananthapuram, Kerala 695607 
 
Primary Sponsor  
Name  Sree Gokulam Medical College 
Address  Sree Goiruvananthapuramkulam Medical College, Venjaramoodu, Th 
Type of Sponsor  Private medical college 
 
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 Simi S M  Sree Gokulam Medical College & Research Foundation  Department of Dermatology/Clinical/Room number 3
Thiruvananthapuram
KERALA 		 9745620025

drsimism@gmail.com 
 
Details of Ethics Committee  
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B950||Streptococcus, group A, as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  98.00 Year(s)
Gender  Both 
Details  Tribals in Agasthyamala Reserve Forest Area of Thiruvananthapuram district
a) Inclusion criteria: i. People of all age group belonging to scheduled tribe and
ii. Should reside in tribal hamlets geographically located under Agasthyamala reserve forest area for atleast 6 months and
iii. who give consent to participate in the study
 
 
ExclusionCriteria 
Details  i. If the study participant is non-traceable in two consecutive home visits by health
ii. If the study participant does not turn up for the second phase of the study, he/she will be excluded from the second phase of study only.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diagnosis made by health worker , Diagnosis made by panel of dermatologists  Diagnosis made by health worker -baseline
Diagnosis made by panel of dermatologists - 3days 
 
Secondary Outcome  
Outcome  TimePoints 
Knowlege, Attitude and Practice of health workers before and after training  3 months 
 
Target Sample Size   Total Sample Size="920"
Sample Size from India="920" 
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)   02/02/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   A diagnostic algorithm to diagnose eleven common skin diseases will be developed partly by literature review and validated by experts. Health workers in the selected tribal hamlets will be trained in diagnosing skin diseases using this algorithm and they will be made to diagnose skin diseases in study population in the selected tribal hamlets. A panel of three dermatologists will independently examine and arrive at clinical diagnosis and this will be taken as the reference standard. The diagnostic performance will be assessed in terms of sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratios. 
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