| CTRI Number |
CTRI/2025/08/092403 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to determine the outcome of the initiating oral spironolactone in the treatment of chronic central serous retinopathy. |
|
Scientific Title of Study
|
A study of efficacy and predictive factors of oral Spironolactone treatment in Chronic Central Serous Retinopathy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NITISHA BAIRWA |
| Designation |
POST GRADUATE RESIDENT OPHTHALMOLOGY |
| Affiliation |
Sawai Man Singh Medical College, Jaipur. |
| Address |
Department of Ophthalmology, Charak Bhawan , JLN Marg , Jaipur.
SMS MEDICAL COLLEGE, JLN Marg , Jaipur 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
8690678513 |
| Fax |
|
| Email |
nitishabairwa371@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagendra Shekhawat |
| Designation |
Sr. Professor , Department of ophthalmology, SMS Hospital, Jaipur |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Ophthalmology, Charak Bhawan, SMS Medical College , Jaipur.
JLN Marg, Jaipur , 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414138567 |
| Fax |
|
| Email |
drnshekhawat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagendra Shekhawat |
| Designation |
Sr. Professor , Department of ophthalmology, SMS Hospital, Jaipur |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Ophthalmology, Charak Bhawan, SMS Medical College , Jaipur.
JLN Marg, Jaipur , 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414138567 |
| Fax |
|
| Email |
drnshekhawat@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Hospital |
| Address |
Department Of Ophthalmology, SMS Medical College and Hospital, Jaipur(302004), Rajasthan, India |
| 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 |
| Dr Nitisha Bairwa |
SMS Medical College and Hospital |
Department of Ophthalmology SMS Medical College and Hospital, Jaipur( 302004)
Jaipur
RAJASTHAN |
8690678513
nitishabairwa371@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H357||Separation of retinal layers, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving informed written consent.
Age group 18 to 50 yrs.
Chronic Central Serous Retinopathy.
Resolution of edema after treatment of Tab Spironolactone. |
|
| ExclusionCriteria |
| Details |
Patients with any other macular pathology.
Patients with previous photocoagulation laser within one year.
Patients with Injection Anti Vascular Growth Factors within one year.
Patients with any contraindication to oral Spironolactone such as kidney or liver disease.
Patients already taking Tab Spironolactone for some other cause.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO study predictive factors for positive response to oral spironolactone treatment among cases of chronic CSR. |
1 week, 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/08/2025 |
| 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
|
It is an observational study being conducted at SMS Medical College and Hospital, at Department of Ophthalmology to evaluate the predictive factors for resolution of edema in the patients of Chronic Central Serous Retinopathy after giving the treatment of Tab Spironolactone for 3 months. All patients diagnosed with chronic CSR will be enrolled and started on Tab Spironolactone 25mg BD for a period of 3 months and will be evaluated for the resolution of edema on OCTA at one week, one month and three months. |