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CTRI Number  CTRI/2017/01/007704 [Registered on: 16/01/2017] Trial Registered Prospectively
Last Modified On: 30/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Cluster Randomized Trial 
Public Title of Study   Reducing Scabies in tribal area of Gadchiroli 
Scientific Title of Study   Field trial of community-based intervention to control scabies in the tribal communities of Gadchiroli, Maharshtra 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyamadhaba Behera 
Designation  In Charge Tribal Health, SEARCH 
Affiliation  SEARCH 
Address  SEARCH Shodhgram PO and District Gadchiroli Maharashtra, India 442605

Gadchiroli
MAHARASHTRA
442605
India 
Phone  9404821908  
Fax  07138-255411  
Email  priya.madhaba@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyamadhaba Behera 
Designation  In Charge Tribal Health, SEARCH 
Affiliation  SEARCH 
Address  SEARCH Shodhgram PO and District Gadchiroli Maharashtra, India 442605

Gadchiroli
MAHARASHTRA
442605
India 
Phone  9404821908  
Fax  07138-255411  
Email  priya.madhaba@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhay Bang 
Designation  Director 
Affiliation  SEARCH 
Address  SEARCH, Shodhgram, Post & district Gadchiroli 442605 Maharashtra, India

Gadchiroli
MAHARASHTRA
442605
India 
Phone  07138255407  
Fax    
Email  search.gad@gmail.com  
 
Source of Monetary or Material Support  
Navajbai Ratan Tata Trust Bombay House Homi Mody street Fort Mumbai 400001 
 
Primary Sponsor  
Name  Society for Education Action and Research in Community Health  
Address  Shodhgram PO and District Gadchiroli,Maharashtra, India 442605 
Type of Sponsor  Other [Non-Governmental Organisation] 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable    
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priyamadhaba Behera  SEARCH  Room no-3 Shrish building Tribal Health
Gadchiroli
MAHARASHTRA 
9404821908
07138-255411
priya.madhaba@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, SEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Scabies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Community-based intervention to control scabies   The community-based intervention package will target all people of the intervention villages. A community survey will be conducted by trained community health workers to address the prevalence of scabies. If the prevalence is found to be less than 10%, then the intervention will include i) Treatment of cases of scabies with two doses of ivermectin (200 microgram per kg) with a gap of 14 days, along with single dose ivermectin (200 microgram per kg) administration to household members unless contraindicated (weight less than 15 kg, pregnant and breastfeeding women, individual with neurologic disease such as parkinson’s disease or cerebral palsy and individual taking medication that is metabolized by the cytochrome p450 pathway eg. warfarin, anticonvulsants). ii) Ivermectin will be replaced by topical permethrin 5% lotion in the above “ivermectin contra-indication” groups. iii) In addition to scabies treatment, the identified infected scabies or impetigo cases will be treated with 0.5% gentian violet paint by health workers. The severe infected scabies and impetigo cases (fever over 101°F, toxic and delirious, severe protein energy malnutrition children with infected scabies or impetigo, patients with more than 40 lesions, no response to health worker treatment) will be referred to the tribal friendly hospital of SEARCH for further management. iv) If the prevalence of scabies is more than 10% in the community, then all the villagers in place of household members of scabies patient in the intervention villages will be treated with a single dose of ivermectin (200 microgram per kg) unless contraindicated 
Comparator Agent  Control arm  The identified cases (scabies, impetigo & infected scabies) will be referred to Mobile Medical Unit (National Rural Health Mission) or Primary Health Care (PHC) for the management according standard guideline. Permethrin 5% will be made available in Mobile Medical Unit (National Rural Health Mission).  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Inclusion criteria:

Cluster/Village level:

1) Tribal village in the field practice area of SEARCH in Gadchiroli district of Maharashtra state of India

2) The village should provide community consent through Gram Sabha for participation in the study.

Individual:
1) Should provide verbal consent for participation in the study.
 
 
ExclusionCriteria 
Details  Exclusion Criteria:
Cluster level:

1) Village with population less than 100

Individual level:

1) Currently on, or has taken ivermectin in the
previous 7 days

2) Has had topical 5% permethrin applied within previous 7 days

3) Seriously ill patients

4) Allergy to any of the components of the allocated drug regimen


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in the prevalence of scabies in the intervention villages as compared to the control villages at the end community-based intervention   2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the prevalence of impetigo in the intervention villages as compared to the control villages at the end community-based intervention   2 months

 
Reduction in the prevalence of scabies in the intervention villages as compared to the control villages after community-based intervention   12 months 
Reduction in the prevalence of impetigo in the intervention villages as compared to the control villages after community-based intervention   12 months 
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="3000" 
Final Enrollment numbers achieved (Total)= "3109"
Final Enrollment numbers achieved (India)="3109" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/01/2017 
Date of Study Completion (India) 30/01/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Published in Plos NTD dated 16th April 2021 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is a cluster randomized, parallel group, two arm controlled trial to assess the effectiveness of community-based intervention to control scabies in the tribal communities of Gadchiroli, Maharashtra. The study will be conducted in the selected 12 villages of Dhanora block of Gadchiroli district.  The community-based intervention package will target all people of the intervention villages. During community survey if the prevalence of scabies  is found to be less than 10%, then the intervention will include i) Treatment of cases of scabies with two doses of ivermectin  (200 microgram per kg) with a gap of 14 days, along with single dose ivermectin (200 microgram per kg) administration to household members unless contraindicated (weight less than 15 kg, pregnant and breastfeeding women, individual with neurologic disease such as parkinson’s disease or cerebral palsy and individual taking medication that is metabolised by the cytochrome p450 pathway eg. warfarin, anticonvulsants). ii) Ivermectin will be replaced by topical permethrin 5% lotion in the above “ivermectin contra-indication” groups. iii) In addition to scabies treatment, the identified infected scabies or impetigo cases will be treated with 0.5% gentian violet paint by health workers. The severe infected scabies and impetigo cases (fever above 101 0F, toxic and delirious, severe protein energy malnutrition children with infected scabies or impetigo, patients with more than 40 lesions, no response to health worker treatment) will be referred to the tribal friendly hospital of SEARCH for further management. iv) If the prevalence of scabies is more than 10% in the community, then all the villagers in place of household members of scabies patient in the intervention villages will be treated with a single dose of Ivermectin (200 microgram per kg) unless contraindicated. The primary outcome will be reduction of prevalence of scabies among people of intervention villages as compared to the control villages at the end of 2 months of community-based intervention. The secondary outcome will be reduction of prevalence of impetigo among people of intervention villages as compared to the control villages after 2 months of community-based intervention. Other secondary outcomes will be reduction of prevalence of scabies and impetigo among people of intervention villages as compared to the control villages after 12 months of community-based intervention.

 
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