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CTRI Number  CTRI/2021/06/034122 [Registered on: 09/06/2021] Trial Registered Prospectively
Last Modified On: 08/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE,OBSERVATIONAL 
Study Design  Other 
Public Title of Study   Clinical and immunological profile of systemic lupus erythematosis with evaluation of disease activity.  
Scientific Title of Study   Clinical and immunological profile of systemic lupus erythematosus with special emphasis on neutrophil lymphocyte ratio and mean platelet volume as markers of disease activity. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Satinder pal singla 
Designation  Junior resident 
Affiliation  Kasturba Medical College Manipal  
Address  Department of general medicine 2nd floor opd block room no 18 Kasturba medical college manipal udupi karnataka
Department of general medicine 2nd floor opd block room no 18 Kasturba medical college manipal udupi karnataka
Udupi
KARNATAKA
576104
India 
Phone  8968259035  
Fax    
Email  satimanu11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Manjunath Hande 
Designation  Professor and HOU  
Affiliation  Kasturba Medical College Manipal  
Address  Department of general medicine 2nd floor opd block room no 18 Kasturba medical college manipal udupi karnataka
Department of general medicine 2nd floor opd block room no 18 Kasturba medical college manipal udupi karnataka
Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  manjunath.hande@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Satinder pal singla 
Designation  Junior resident 
Affiliation  Kasturba Medical College Manipal  
Address  Department of general medicine 2nd floor opd block room no 18 Kasturba medical college manipal udupi karnataka
Department of general medicine 2nd floor opd block room no 18 Kasturba medical college manipal udupi karnataka
Udupi
KARNATAKA
576104
India 
Phone  8968259035  
Fax    
Email  satimanu11@gmail.com  
 
Source of Monetary or Material Support  
KASTURBA MEDICAL COLLEGE AND HOSPITAL, MANIPAL UDUPI- 576104 KARNATAKA 
 
Primary Sponsor  
Name  DR Manjunath Hande 
Address  Department of general medicine 2nd floor opd block room no 18 Kasturba medical college manipal udupi karnataka 
Type of Sponsor  Other [Individual] 
 
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 Satinder pal singla  Kasturba Hospital, Manipal  Department of general medicine 2nd floor opd block room no 18 Kasturba medical college manipal udupi karnataka
Udupi
KARNATAKA 
8968259035

satimanu11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Kasturba Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M32||Systemic lupus erythematosus (SLE),  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients >18-year-old diagnosed as SLE with new ACR and EULAR criteria/ SLICC criteria  
 
ExclusionCriteria 
Details  Patient with sepsis/other active infections
Overlap syndromes with other rheumatological diseases
Acute/chronic kidney disease (other than lupus nephritis)
Leukaemia, lymphoma, malignancies
Vasculitis
Acute MI, Acute stroke
Patients on systemic steroids >5mg/day
Uncontrolled diabetes HbA1c > 7%

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To have good study about the clinical characteristics of patients of SLE presenting to the hospital
To know the immunological profile of patients of SLE
 
At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
significant increase in neutrophil lymphocyte ratio in people with active SLE
significant reduction in mean platelet volume in patients with active SLE active SLE based on SLEDAI score
 
At baseline 
 
Target Sample Size   Total Sample Size="123"
Sample Size from India="123" 
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)   20/06/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

SLE is a systemic autoimmune disease of unknown etiology with varied clinical and laboratory characteristics, it can potentially cause substantial physical and functional disability, ranging from a rash to renal failure or even death. There is a lack of SLE registries from INDIA, which poses as a major barrier to understand patient and disease characteristics. To predict the SLE flare, we currently have a 24 parameter SLEDAI score, but no single lab test exists to recognize the flare and increase in SLE disease activity. Several studies suggest that people with active SLE have neutrophilia and lymphopenia. The presence of Anti lymphocyte antibody is important in the mechanism of lymphopenia in SLE. Platelet activation is observed in patients with SLE due to inflammatory cytokines and complement. There occurs consumption of large activated platelets in extravascular sites of inflammation. In this study we will understand the profile of SLE in patients presenting to a tertiary care hospital and we will correlate the role of NLR and MPV in identifying the SLE flare. Also, NLR and MPV are readily available even at a PHC, thus increasing the chances of identifying the SLE flare at every level of healthcare.  

 
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