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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M32||Systemic lupus erythematosus (SLE), |
|
Intervention / Comparator Agent
|
|
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. |