| CTRI Number |
CTRI/2024/03/063418 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A novel inflammatory marker to find out the association of inflammation in the patients diagnosed with fibromyalgia. |
|
Scientific Title of Study
|
"A single-centric, assessor-blinded observational non-inferiority study to elicit the association of systemic immune inflammation index(SII) in patients diagnosed with fibromyalgia" |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunaina Mahapatra |
| Designation |
Fellow resident |
| Affiliation |
Daradia the pain clinic |
| Address |
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
9438404392 |
| Fax |
|
| Email |
drsunaina91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautam Das |
| Designation |
Director |
| Affiliation |
Daradia the pain clinic |
| Address |
Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
9163357246 |
| Fax |
|
| Email |
gdas2310@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautam Das |
| Designation |
Director |
| Affiliation |
Daradia the pain clinic |
| Address |
Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
9163357246 |
| Fax |
|
| Email |
gdas2310@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daradia the pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Self] |
|
|
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 Sunaina Mahapatra |
Daradia the pain clinc |
Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
Kolkata
WEST BENGAL |
09438404392
drsunaina91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DARADIA ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M797||Fibromyalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patient diagnosed with fibromyalgia not under treatment |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All demographic data among both the group will be noted .Hemoglobin, neutrophil, lymphocyte, monocyte, and platelet counts, MPV, NLR, PLR, MLR, and SII will be analyzed. SII will be calculated by multiplying the NLR and the platelet count. |
at the time of first visit to clinic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| : The disease activity and the level of depression in relation to SII score will be recorded using Fibromyalgia Impact Questionnaire (FIQ) and PHQ9 rating scale respectively prior to initiation of any treatment. |
at the time of first visit to clinic |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
Final Enrollment numbers achieved (Total)= "156"
Final Enrollment numbers achieved (India)="156" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
05/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
We postulate that the disease Fibromyalgia has an inflammatory component, hence an positive association of Systemic immune inflammatory index(SII) with the diseases activity can be elicited. SII has recently been investigated in the field of rheumatology and its relationship with activity has only been reported in Ankylosing Spondylitis. There is no similar study yet in patients with fibromyalgia to the best of our knowledge. In this study, we aimed to investigate the relationship of SII with clinical conditions such as disease activity and depression.
|