| 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
|
|
|
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
|
|
|
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. |