| CTRI Number |
CTRI/2024/10/075300 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Drug prescribing pattern in the Psychiatry OPD for the mental illnesses of the patients |
|
Scientific Title of Study
|
Drug utilization study in Psychiatry OPD of a tertiary care hospital: 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 Susmita Patwary |
| Designation |
Post graduate trainee in Department of Pharmacology |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Department of Pharmacology, R. G. Kar Medical College and
Hospital, 1, Khudiram Bose Sarani, Kolkata-700004.
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831138264 |
| Fax |
|
| Email |
patwary.susmita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Lopamudra Dhar Chowdhury |
| Designation |
Professor and Head in Department of Pharmacology |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Department of Pharmacology, R. G. Kar Medical College and
Hospital, 1, Khudiram Bose Sarani, Kolkata-700004.
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433135767 |
| Fax |
|
| Email |
drlopamudra@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Susmita Patwary |
| Designation |
Post graduate trainee in Department of Pharmacology |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Department of Pharmacology, R. G. Kar Medical College and
Hospital, 1, Khudiram Bose Sarani, Kolkata-700004.
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831138264 |
| Fax |
|
| Email |
patwary.susmita@gmail.com |
|
|
Source of Monetary or Material Support
|
| R. G. Kar Medical College and Hospital, Kolkata - 700004, West Bengal. |
|
|
Primary Sponsor
|
| Name |
R.G. Kar Medical College and Hospital |
| Address |
R. G. Kar Medical College and
Hospital, 1, Khudiram Bose Sarani, Kolkata-700004. |
| 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 Susmita Patwary |
R. G. Kar Medical College and Hospital, Kolkata. |
Psychiatry Out Patient Department(Room no 404 of OPD building)
Kolkata
WEST BENGAL |
9831138264
patwary.susmita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, R. G. Kar Medical College and Hospital, Kolkata-700004 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
88.00 Year(s) |
| Gender |
Both |
| Details |
All patients attending Psychiatry OPD in this period. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Drugs used and psychiatric diseases prevalent |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sociodemographic profile of these patients |
6 months |
|
|
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)
|
01/11/2024 |
| 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
|
This is an observational cross-sectional study and will be conducted in Psychiatry OPD for 6 months, to delineate the use of various drugs in different psychiatric illnesses as well as to find out the psychiatric diseases commonly in the OPD and the sociodemographic profile of these patients. Across 6months, around 400 patients attending the Psychiatry OPD of R. G. Kar Medical College and Hospital, Kolkata, will be randomly selected and with proper consent their prescriptions will be studied for collection of relevant data and they will be only questioned regarding their occupation and their address as urban or rural. Finally the percentage of the psychiatric illnesses commonly found in the Psychiatry OPD and the trends of the drugs utilised in the prescriptions will be calculated as a percentage. |