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CTRI Number  CTRI/2025/07/089960 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 23/02/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Blood test to detect venomous snake bite 
Scientific Title of Study   Assessing for Utility of Phospholipase A2 ELISA in Snakebite victims 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shailaja S 
Designation  Professor 
Affiliation  Father Muller Medical College 
Address  Dept of Emergency Medicine, Father Muller Medical College Mangalore,

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845663466  
Fax    
Email  drshaila@fathermuller.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailaja S 
Designation  Professor 
Affiliation  Father Muller Medical College 
Address  Dept of Emergency Medicine, Father Muller Medical College, Mangalore,

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845663466  
Fax    
Email  drshaila@fathermuller.in  
 
Details of Contact Person
Public Query  
Name  Dr Shailaja S 
Designation  Professor 
Affiliation  Father Muller Medical College 
Address  Dept of Emergency Medicine, Father Muller Medical College Mangalore,

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845663466  
Fax    
Email  drshaila@fathermuller.in  
 
Source of Monetary or Material Support  
Father Muller Charitable Institutions, Kankanady, Mangalore - 575002 
 
Primary Sponsor  
Name  FMCI 
Address  Father Muller Medical College Kankanady Mangalore - 575002 
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 Shailaja S  Father Muller Medical College  Dept of Emergency Medicine, Father Muller Medical College, Kankanady Mangalore - 575002
Dakshina Kannada
KARNATAKA 		 09845663466

drshaila@fathermuller.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: X398||Other exposure to forces of nature,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients coming with history of snake bite 
 
ExclusionCriteria 
Details  History of chronic inflammatory diseases or autoimmune conditions, use of anti-venom before hospital admission, patients on medications that may influence PLA2 levels (e.g., steroids, NSAIDs and amiodarone) Patients who have received Anti snake venom from outside hospital. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Utility of PLA2 in snake bite patients   On arrival - 0 hour and 3 hours after anti snake venom  
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of snakebite severity score & morbidity  On admission - 0 hours & at time of discharge 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/07/2025 
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="3"
Days="8" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 After data collection and manuscript preparation, it will be notified 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Publication

  6. For how long will this data be available start date provided 02-12-2026 and end date provided 02-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  		 Background - Snakebite is a significant public health problem in India and recently also declared as a notifiable disease. Early identification of systemic envenomation is crutial for timely ASV administration. 20 minute whole blood clotting time is the commonly used bedside test to detect envenomation. However it lack sensitivity and specificity. Phospholipase A2 is a major enzymatic component of elapid and viper species. Hence it has emerged as a biomarker for detecting envenomation using ELISA based assays.
Objective - To evaluate the diagnostic utility of serum PLA2 measured by ELISA for detecting venomous and non venomous snakes.
Methodology - Hospital based cases control study done in the emergency medicine department of Father Muller Medical College. 100 cases of venomous bites and 100 cases on non venomous bites patients blood will be tested for levels of serum PLA2 using ELISA kits. Diagnostic performance will be assessed using sensitivity, specificity and area under curve. Relevant clinical and Laboratory parameters will be noted down.
Expected outcome - This study aims to determine whether serum PLA2 can serve as a biomarker for detecting venomous snake, support in the daignostic tool in resource limited settings.
 
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