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CTRI Number  CTRI/2013/08/003886 [Registered on: 08/08/2013] Trial Registered Retrospectively
Last Modified On: 03/08/2013
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A STUDY OF LONG TERM EFFECTS OF SNAKEBITE ENVENOMATION 
Scientific Title of Study   A PROSPECTIVE STUDY OF MORTALITY AND LONG TERM MORBIDITY IN SNAKEBITE VICTIMS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR KUMAR 
Designation  POSTGRADUATE RESIDENT 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  FIRST YEAR POSTGRADUATE RESIDENT DEPARTMENT OF MEDICINE FATHER MULLER MEDICAL COLLEGE Father Muller Road, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575 002
India 
Phone  8197445189  
Fax    
Email  kumarkenchetty@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR K S BHAT 
Designation  PROFESSOR 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  PROFESSOR DEPARTMENT OF MEDICINE FATHER MULLER MEDICAL COLLEGE Father Muller Road, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575 002
India 
Phone  9845099492  
Fax    
Email  drksbhat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR KUMAR 
Designation  POSTGRADUATE RESIDENT 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  FIRST YEAR POSTGRADUATE RESIDENT DEPARTMENT OF MEDICINE FATHER MULLER MEDICAL COLLEGE Father Muller Road, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575 002
India 
Phone  8197445189  
Fax    
Email  kumarkenchetty@gmail.com  
 
Source of Monetary or Material Support  
self 
 
Primary Sponsor  
Name  DR KUMAR 
Address  POST GRADUATE RESIDENT DEPARTMENT OF MEDICINE FATHER MULLER MEDICAL COLLEGE Father Muller Road, Kankanady, Mangalore - 575 002,Karnataka INDIA 
Type of Sponsor  Other [SELF] 
 
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 KUMAR  FATHER MULLER MEDICAL COLLEGE  ROOM NUMBER 27 DEPARTMENT OF MEDICINE FATHER MULLER MEDICAL COLLEGE Father Muller Road, Kankanady, Mangalore - 575 002,Karnataka INDIA
Dakshina Kannada
KARNATAKA 
8197445189

kumarkenchetty@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL EHTICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  snakebite victims,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  snakebite victims with envenomation 
 
ExclusionCriteria 
Details  snakebite victims without envenomation 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
death  6 month 
 
Secondary Outcome  
Outcome  TimePoints 
deformities, functional impairment  6 month 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   20/11/2012 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

        Snakebite is an important medical emergency and occupational hazard in the rural tropics especially India where agriculture is a major source of employment.

      India has the highest number of deaths due to snakebites with 81,000 envenomations and 11,000 deaths every year ; although the actual incidence may be much higher as many cases go unreported in villages. Despite the high mortality, snakebite remains a neglected public health problem.

      The case fatality rate in India varies from 1.7-20%.  The wide variation could be due to non-availability of medical facilities in remote rural areas compelling many victims to resort to primitive traditional methods of treatment. Quick recognition and treatment with anti snake venom (ASV) is essential in order to restore coagulation and reverse other signs of systemic envenomation and thus avoid severe morbidity and mortality. However a review of current literature shows a lack of monitoring of morbidity related to snakebite envenomation in India. This is unfortunate as most of the snakebite victims are in the economically productive age group and thus the economic impact of the disability is likely to be high.

      The goal in treatment of snakebite envenomation should be to prevent or reduce all grades of injury, not just those that are life threatening. The first step in this direction would be to estimate the morbidity produced by snakebite envenomation so that effective steps may be taken in the treatment.

        Hence the study aims to determine mortality and long term morbidity in snakebite victims admitted to Fr Muller Medical College Hospital. 
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