| CTRI Number |
CTRI/2024/07/071591 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Platelet Indices in assessing Non Radiographic Axial Spondyloarthritis |
|
Scientific Title of Study
|
Platelet indices as unequivocal markers of active disease in patients of non-radiographic axial Spondyloarthritis: An observational study |
| 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 Abhijeet Kumar Agrawal |
| Designation |
Associate Professor, Dept. of medicine |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
Dept of Medicine
3rd Floor
Block A
Wardha
MAHARASHTRA
442001
India |
| Phone |
9767611889 |
| Fax |
|
| Email |
abhijeet.agrawal89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sourya Acharya |
| Designation |
Professor, Dept. of medicine |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
Dept of Medicine
3rd floor
Block A
MAHARASHTRA
442001
India |
| Phone |
9767611889 |
| Fax |
|
| Email |
souryaacharya74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijeet Kumar Agrawal |
| Designation |
Associate Professor, Dept. of medicine |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
Dept of Medicine
3rd floor
block A
MAHARASHTRA
442001
India |
| Phone |
9767611889 |
| Fax |
|
| Email |
abhijeet.agrawal89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Rsearch |
| Address |
Dept. of Medicine, 3rd floor, Block A
AVBRH Hospital, Wardha, Maharashtra, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Abhijeet Kumar Agrawal |
Datta Meghe Institute of Higher Education and Research |
Dept of medicine
3rd floor
block A
Wardha
MAHARASHTRA |
9767611889
abhijeet.agrawal89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M468||Other specified inflammatory spondylopathies, (2) ICD-10 Condition: M468||Other specified inflammatory spondylopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed with axial spondyloarthritis as per ASAS criteria above the age of 16 years and giving consent will be included in this study. |
|
| ExclusionCriteria |
| Details |
Patients with metabolic disorders, recent pregnancy, known case of tuberculosis/brucellosis/Active infections, malignancy, trauma, crystal arthropathy, h/o vasculitis, h/o hemoglobinopathies, smokers, patients on antiplatelet drugs and patients not consenting will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Platelet Indices Proving to be Reliable markers of active disease in Patients of non-radiographic axial Spondyloarthritis |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Biomarkers such as CRP to Albumin ratio, Platelet to lymphocyte ratio, Complement 3 as surrogate markers of disease activity in non radiographic axial Spondyloarthritis |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="197"
Sample Size from India="197"
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)
|
01/08/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The patients of spondyloarthritis including both non radiological axial SpA and Ankylosing Spondylitis will be included in this study as cases. Platelet indices in both these groups will be compared with existing markers of disease activity such as CRP and MRI pelvis. along with platelet indices, C3, ESR, Neutrophil to lymphocyte ratio, platelet to lymphocyte ratio and CRP to albumin ratio will also be compared. same comparison will be done with the control group of normal individuals. |