| CTRI Number |
CTRI/2025/03/083076 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study observing the drugs being prescribed to the patients visiting Ophthalmology department of Sawai Man Singh Hospital Jaipur. |
|
Scientific Title of Study
|
A descriptive observational study on prescribing pattern of drugs among patients attending out patient department of Ophthalmology at Sawai Man Singh Hospital Jaipur. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABHISHEK BAIWAL |
| Designation |
Postgraduate Resident |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829616100 |
| Fax |
|
| Email |
abhibaiwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupa Kapadia |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9929871911 |
| Fax |
|
| Email |
drrupakapadia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupa Kapadia |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9929871911 |
| Fax |
|
| Email |
drrupakapadia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sawai Man Singh Medical College and attached Hospital, Jaipur, Rajasthan, India (Pin code:302004) |
|
|
Primary Sponsor
|
| Name |
ABHISHEK BAIWAL |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur |
| 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 |
| ABHISHEK BAIWAL |
Sawai Man Singh Hospital |
Room no. 5, OutPatient Department, Department of Ophthalmology, Sawai Man Singh Hospital, Jaipur
Jaipur
RAJASTHAN |
9829616100
abhibaiwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, SMS Medical College and Attached Hospitals, Jaipur |
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 |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Newly diagnosed cases of ocular diseases attending out patient department (OPD) with or
without co morbidities.
2.Patients of either sex of all age group.
3.Patients who are willing to participate and has given written consent. |
|
| ExclusionCriteria |
| Details |
1.Post-operative/follow-up patients.
2.Traumatic or critically ill patients.
3.Patients with refractive error only. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Average number of drugs per encounter(per prescription).
2.Percentage of drugs prescribed with the generic name.
3.Percentage of encounters (per prescription) with antibiotics prescribed.
4.Percentage of encounters (per prescription) with injections prescribed.
5.Percentage of drugs prescribed from Essential Drugs List (EDL).
6.Distribution of prescribed drugs according to Anatomic Therapeutic Chemical classification with their calculated Daily Defined Dose. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To study self medications practices among enrolled patients. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
15/04/2025 |
| 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="0"
Months="6"
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
|
The incidence of various eye diseases in a community or area varies with the social and environmental factors.The purpose of this study is to systematically analyse and understand the current prescribing patterns of prescribed drug by using WHO core indicators and to classify the prescribed drugs as per the anatomical Therapeutic Chemical classification system and measures there Defined Daily Dose in patients.
|