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CTRI Number  CTRI/2024/04/065814 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 01/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Estimation of levels of Serum neurofilament light chains in leprosy patients with peripheral neuropathy 
Scientific Title of Study   Assessment of serum neurofilament light chains in leprosy associated peripheral neuropathy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
694(08/2024)/IEC/ABVIMS/RMLH)/02  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ananta Khurana 
Designation  Professor 
Affiliation  Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital 
Address  OPD room no 109, Department of dermatology, venereology and leprosy, ABVIMS and Dr RML Hospital, Baba Kharak Singh Marg road Connaught place, New Delhi

Central
DELHI
110001
India 
Phone  9212370467  
Fax    
Email  drananta2014@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ananta Khurana 
Designation  Professor 
Affiliation  Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital 
Address  OPD room no 109, Department of dermatology, venereology and leprosy, ABVIMS and Dr RML Hospital, Baba Kharak Singh Marg road Connaught place, New Delhi

Central
DELHI
110001
India 
Phone  9212370467  
Fax    
Email  drananta2014@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ananta Khurana 
Designation  Professor 
Affiliation  Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital 
Address  OPD room no 109, Department of dermatology, venereology and leprosy, ABVIMS and Dr RML Hospital, Baba Kharak Singh Marg road Connaught place, New Delhi

Central
DELHI
110001
India 
Phone  9212370467  
Fax    
Email  drananta2014@gmail.com  
 
Source of Monetary or Material Support  
Indian Association of Dermatology, venereology and leprosy 
National Institute of Mental Health and Neurosciences,Bengaluru 
 
Primary Sponsor  
Name  Indian Association of Dermatology, Venereology and Leprosy 
Address  IADVL National Headquarters 314-315, 3rd Floor KM Trade Tower, H 3, Sector 14, Kaushambi, Ghaziabad, Uttar Pradesh. 201010 
Type of Sponsor  Other [Official Society of Indian Dermatologists] 
 
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 Prof Ananta Khurana  Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital   OPD no 109, first floor, Department of Dermatology, Venereology and Leprosy, ABVIMS and Dr RML Hospital, Baba Kharak Singh Marg Road, New Delhi
Central
DELHI 
9212370467

drananta2014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A309||Leprosy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult Patients diagnosed with leprosy with and without peripheral neuropathy.
2. Age and sex matched healthy controls.
 
 
ExclusionCriteria 
Details  1. Any alternate diagnosis of peripheral neuropathy
2. Presence of diabetes
3. History of chronic alcoholism
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the serum levels of neurofilament light chains in patients with peripheral neuropathy of leprosy and compare it with levels in patients of leprosy without peripheral neuropathy, and healthy controls  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To understand the role of neurofilament light chains in the early detection of peripheral neuropathy in leprosy patients  6 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   22/04/2024 
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 - NO
Brief Summary  

Leprosy causes a peripheral sensory-motor neuropathy with affliction of sensory pathways usually preceding motor involvement. The nerve damage is a major cause of disability related to leprosy and contributes significantly to the stigma associated to the infection as well. Although effective multi drug therapy works to clear the bacterial load, the occurrence of peripheral neuropathy does not seem to be prevented and its occurrence, progression and recovery is unpredictable. Steroids are not uniformly effective in treating the peripheral neuropathy and newer drugs are urgently required to manage this distressing complication of leprosy.

Serum neurofilament light chains (NFL) were initially assessed in CSF in neurodegenerative disorders like Alzeihmer’s disease and multiple sclerosis. The significance in many such disorders is now well established and the marker is now used for treatment assessment in therapeutic trials of these diseases as well. With the advent of highly sensitive single molecular arrays (SIMOA), it is now possible to measure very small levels of NFLs in serum too. Further, in past few years the marker has been evaluated in some peripheral neuropathies also and shown to be of relevance. With this background we aim to assess serum NFL levels in patients with peripheral neuropathy of leprosy and compare it with levels in patients of leprosy without peripheral neuropathy, and healthy controls, to understand whether NFL can have a role in early detection of peripheral neuropathy of leprosy.

 
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