| CTRI Number |
CTRI/2025/07/091060 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Estimation of prevalence of depression in patients with diabetic retinopathy:a cross sectional descriptive study |
|
Scientific Title of Study
|
Estimation Of Prevalence Of Depression In Patients With
Diabetic Retinopathy:A Cross Sectional Descriptive 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 Kaushik Patil |
| Designation |
Junior Resident |
| Affiliation |
JNMC MEDICAL COLLEGE,KLE |
| Address |
Department Of Psychiatry OPD 15 , JNMC, KLE University, Belgaum, Karnataka
590019
India
Belgaum
KARNATAKA
590019
India |
| Phone |
9359819577 |
| Fax |
|
| Email |
kaushik101520@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bheemsain Tekkalaki |
| Designation |
Associate Professor,Department Of Psychiatry,KAHERS KLE INSTITUTE,BELGAUM |
| Affiliation |
JNMC MEDICAL COLLEGE,KLE |
| Address |
Department Of Psychiatry OPD 15 ,JNMC KLE University, Belgaum, Karnataka
590019
India
Belgaum
KARNATAKA
590019
India |
| Phone |
9886674849 |
| Fax |
|
| Email |
TBHEEMSAIN@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaushik Patil |
| Designation |
Junior Resident |
| Affiliation |
JNMC MEDICAL COLLEGE,KLE |
| Address |
Department Of Psychiatry OPD 15 ,JNMC KLE University, Belgaum, Karnataka
590019
India
Belgaum
KARNATAKA
590019
India |
| Phone |
9359819577 |
| Fax |
|
| Email |
kaushik101520@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kles Prabhakar Kore Hospital,nehru nagar.belagavi,karnataka,india,590010 |
|
|
Primary Sponsor
|
| Name |
DR KAUSHIK PATIL |
| Address |
Department of Psychiatry,Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi 590019, Karnataka, India |
| 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 KAUSHIK PATIL |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre |
Department Of Ophthalmology,Opd No 17, Kles Dr. Prabhakar Kore Hospital,Belagavi, Karnataka
Belgaum
KARNATAKA |
9359819577
kaushik101520@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| jnmc institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of 18 years of age and above
Patients diagnosed with Diabetic Retinopathy
Patients who are willing to give informed consent |
|
| ExclusionCriteria |
| Details |
Patients having history of any major psychiatric illness
Patients having other serious diseases and other chronic medical conditions (such as cancers, Parkinsons disease ).
Patients having other diabetes related comorbidities (such as diabetic nephropathy) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of depression in patients with diabetic retinopathy |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the association between various
sociodemographic & clinical variables & depression among patients with
Diabetic Retinopathy |
baseline |
|
|
Target Sample Size
|
Total Sample Size="218"
Sample Size from India="218"
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)
|
28/07/2025 |
| 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 Yet Recruiting |
| 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
|
There are not many studies available in India exploring correlation between Diabetic Retinopathy and Depression. Considering the cultural differences and difference in compliance to treatment it is worthwhile to study what happens to the Indian diabetic population and the prevalence of depression and factors affecting the depression. Also to assess the factors that affect the development of depression. |