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CTRI Number  CTRI/2025/09/094381 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Risk factors evaluation for lepra reactions 
Scientific Title of Study   Evaluation of risk factors and serological determinant ( anti PGL1) in Lepra Reactions in tertiary care institute 
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 Ayush Bhatnagar 
Designation  Post Graduate Student 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Room no. 1 Department of Dermatology 1st Floor, D-Block AIIMS Campus Tatibandh Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8826045002  
Fax    
Email  ayush11.bhatnagar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Namrata Chhabra 
Designation  Post Graduate Student 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Room No. 2 Department of Dermatology 1st Floor, D-Block
AIIMS Campus Tatibandh Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  8826045002  
Fax    
Email  namrata81@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Ayush Bhatnagar 
Designation  Post Graduate Student 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Room NO. 1 Department of Dermatology 1st Floor, D-Block
AIIMS Campus Tatibandh Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  8826045002  
Fax    
Email  ayush11.bhatnagar@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Raipur 
 
Primary Sponsor  
Name  Ayush Bhatnagar 
Address  All India Institue of Medical Sciences Room No. 1, 1st Floor, D-Block Department of Dermatology AIIMS campus Tatibandh Raipur Chhattisgarh 
Type of Sponsor  Government 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 Ayush Bhatnagar  All india Institute of Medical sciences, Raipur  Room No.1, 1st Floor, D-Block Department of Dermatology AIIMS Campus Tatibandh, Raipur
Raipur
CHHATTISGARH 		 8826045002

ayush11.bhatnagar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A305||Lepromatous leprosy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All leprosy patients (both new and old) 
 
ExclusionCriteria 
Details  Pregnant and lactating females
Patients not willing to participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine risk factors in lepra reactions
Age
Gender
Socio-economic status
Spectrum of leprosy 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To determine Anti- PGL1 levels  6months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   18/09/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
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
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ayush11.bhatnagar@gamil.com].

  6. For how long will this data be available start date provided 11-04-2025 and end date provided 11-04-2030?
    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 - No
Brief Summary  

Leprosy is a chronic infectious disease caused by Mycobacteria leprae and is one of the major public health problem in India. Lepra reactions are autoimmune reactions mediated against lepra bacilli which presents as systemic inflammatory complications in the form of medical emergencies which are mainly of two types: Type 1 ( Reversal Reactions) and Type 2(Erythema Nodosum Leprosum). 

The risk factors associated with leprosy are not very clearly defined. Various studies have tried to identify clinical, epidemiological and laboratory risk factors for lepra reactions. They found out that old age, poor nutritional status, low BMI, coinfections, multi bacillary patients, patients with leukocytosis, thrombocytopenia, anemia were at increased risk for the development of leprosy reactions. Anti PGL1 (Phenolic Glycolipid 1) seropositivity showed greater chances for development of leprosy reactions and its level also showed a prognostic value in type 2 leprosy reactions. So far there has been no study to identify risk factors for leprosy reactions from Chhattisgarh where leprosy is endemic.

Our objective is to determine risk factors and Anti PGL1 antibody levels in leprosy reactions.

This is a cross sectional analytical study consisting of two groups of 30 patients each where group I will include leprosy patients without leprosy reactions and group II will include leprosy patients with leprosy reactions. The study will be conducted over a period of one and half years.

A detailed history will be noted, examination and relevant investigations will be conducted for all patients fulfilling the inclusion criteria and after obtaining valid written consent. Then 5ml of venous blood will be taken for the estimation of PGL1 levels using ELISA kits. The clinic-epidemiological and laboratory parameters including Anti PGL1 levels will be compared in the two groups.

Data will be entered in a excel sheet and will be analyzed using appropriate statistical tests.