| CTRI Number |
CTRI/2025/04/085078 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Association Of Neutrophil Lymphocyte Ratio With Diabetic Retinopathy In Type 2 Diabetes Mellitus Pateints At Tertiary Care Centre. |
|
Scientific Title of Study
|
Association Of Neutrophil Lymphocyte Ratio With Diabetic Retinopathy In Type 2 Diabetes Mellitus Patient In Tertiory Care Centre A Cross Sectional 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 Swetha Mallika |
| Designation |
Resident Doctor |
| Affiliation |
Government medical college Bhavnagar |
| Address |
room no 62 General Medicine block Sir T Hospital Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
7013979506 |
| Fax |
|
| Email |
swethakrishna33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swetha Mallika |
| Designation |
Resident Doctor |
| Affiliation |
Government medical college Bhavnagar |
| Address |
Room no 62 General Medicine block Sir T Hospital Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
7013979506 |
| Fax |
|
| Email |
swethakrishna33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Akholkar |
| Designation |
Associate Professor |
| Affiliation |
General medical college Bhavnagar |
| Address |
Room no 62 General Medicine block Sir T Hospital Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825312175 |
| Fax |
|
| Email |
Drpankaj_md@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room number 62 General medicine block Government medical college, Bhavnagar, Gujarat 364001. |
|
|
Primary Sponsor
|
| Name |
Dr Swetha Mallika |
| Address |
Government Medical College Bhavnagar Gujarat 364001 |
| Type of Sponsor |
Government 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 |
| DRSWETHA MALLIKA |
Sir T Hospital, Bhavnagar. |
Room no 62, General Medicine block, Sir T Hospital, Bhavnagar, Gujarat, 364001.
Bhavnagar
GUJARAT |
7013979506
swethakrishna33@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee Government Medical College Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All diagnosed type 2 diabetes mellitus patients admitting in medicine ward of Sir T Hospital Bhavnagar during the period. |
|
| ExclusionCriteria |
| Details |
Acute and chronic infection conditions
Drugs effecting neutrophil and lymphocyte counts
Auto immune disorders
Alcoholics
Smokers |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess if Neutrophil lymphocyte ratio can be used as an inflammatory marker In Diabetic Retinopathy in Type 2 Diabetic patients. |
Baseline, After 4 Weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess if neutrophil lymphocyte ratio can be used as a predictive marker in diagnosing the severity of diabetic retinopathy. |
9months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/06/2025 |
| 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="1"
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
|
As often India is referred to as Diabetes Capital or Diabetes Hub of the world. So diagnosing diabetes at early stage and getting adequate management accordingly and preventing the micro and macrovascular complications from diabetes plays a crucial role. But as India is a Developing country, many people living in remote areas and small towns are not accessible for basic as well as advanced laboratory tools for diagnosing diabetic complications at earliest as possible. These microvascular complications attribute to substantial rise in mortality and reduction of quality of life in diabetics. The Neutrophil Lymphocyte ratio is a simple and cost effective laboratory tool which can predict the prognosis and severity of diabetic retinopathy and can be used as a Screening tool in places with limited resources like India. |