| CTRI Number |
CTRI/2023/02/049946 [Registered on: 21/02/2023] Trial Registered Prospectively |
| Last Modified On: |
02/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of Uses and prescribing pattern of different psychotropic drugs used for various psychiatric disorders in Psychiatry OPD |
|
Scientific Title of Study
|
Utilization and Prescription Pattern of Psychotropic drugs in Psychiatry outpatient department at a tertiary care hospitalKolkata |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrIpsita Paul |
| Designation |
Post GraduateTrainee of Department of Pharmacology |
| Affiliation |
College of Medicine and Sagore Dutta Hospital Kamarhati Kolkata |
| Address |
Department of Pharmacology 5th floor, Academic building, College of Medicine and Sagore Dutta Hospital578 BT Road Kamarhati Kolkata700058
3no.Chandigarh madhyamgram PO Madhyamgram Bazar Dist North 24pgs Kolkata700130
North Twentyfour Parganas
WEST BENGAL
700058
India |
| Phone |
7001058169 |
| Fax |
|
| Email |
dripsitapaul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPrithwijit Banerjee |
| Designation |
Associate Professor of department of Pharmacologyy |
| Affiliation |
College of Medicine and Sagore Dutta Hospital Kamarhati Kolkata |
| Address |
Department of Pharmacology,5th floor, Academic Building, College of Medicine and Sagore Dutta Hospital 578 BT Road Kamarhati Kolkata700058
North Twentyfour Parganas
WEST BENGAL
700058
India |
| Phone |
9830500513 |
| Fax |
|
| Email |
drprithwijit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrIpsita Paul |
| Designation |
Post GraduateTrainee of Department of Pharmacology |
| Affiliation |
College of Medicine and Sagore Dutta Hospital Kamarhati Kolkata |
| Address |
Department of Pharmacology,5th floor, Academic Building College of Medicine and Sagore Dutta Hospital578 BT Road Kamarhati Kolkata700058
3no.Chandigarh madhyamgram PO Madhyamgram Bazar Dist North 24pgs Kolkata700130
North Twentyfour Parganas
WEST BENGAL
700058
India |
| Phone |
7001058169 |
| Fax |
|
| Email |
dripsitapaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ipsita Paul(self-sponsored) Post graduate trainee of department of Pharmacology,5th floor, Academic Building, College of Medicine and Sagore Dutta Hospital 578,BT Road,700058 |
|
|
Primary Sponsor
|
| Name |
DrIpsita Paul |
| Address |
Department of Pharmacology ,5th floor, Academic Building College of Medicine and Sagore Dutta Hospital 578 BT Road Kamarhati Kolkata700058 |
| 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 Ipsita Paul |
College of Medicine and Sagore Dutta Hospital |
Department of Pharmacology,5th floor, Academic Building, College of Medicine and Sagore Dutta Hospital 578 BT Road,Kamarhati, Kolkata700058
North Twentyfour Parganas
WEST BENGAL |
7001058169
dripsitapaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,College of Medicine and Sagore Dutta Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients of either sex pregnant and lactating women patients suffering from terminal illness or malignancies suicidal history of substance abuse who will give consent |
|
| ExclusionCriteria |
| Details |
Patients who will refuse to give written informed consent. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To document usage and prescribing pattern of psychotropic drugs in patients attending psychiatry outpatient department for various indications at a tertiary care hospital kolkata. The different psychotropic drugs prescribed in Psychiatry OPD will be documented in details regarding exact dosage, frequency, strength,duration and indications of their use. |
It is a cross-sectional type of study. data will be collected over 32weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study WHO core prescribing indicators of prescription encountered.WHO drug use indicators are prescribing,patient care and facility indicators asper guidelines. WHO core indicators include drug data ,prescriber related data and demographic data. WHO core indicators includes number of drugs,number of branded/generic drugs and number of antimicrobials/ injections etc will be recorded. |
It is a cross-sectional type of study .data will be collected over 32weeks. |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
01/03/2023 |
| 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
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A cross-sectional study of drug Utilization and Prescription pattern of Psychotropic drugs in patients attending Psychiatry outpatients department will be conducted in collaboration with department of pharmacology at College of Medicine and sagore Dutta Hospital, Kamarhati, Kolkata.Main Objective of study is to document usage and prescribing pattern of psychotropic drugs in patients attending Psychiatry outpatient department for various indications(schizophrenia,Psychosis, depression, insomnia, mood disorder, eating disorder etc) and to study WHO core prescribing indicators of prescription encountered. WHO drug use indicators are prescribing , patients care and facility indicators as per guidelines. This study is necessary to know current trends of usage of psychotropic drugs as newer agents of this class of drug is introduced in rapidly expanding field which are more safer and efficacious.drug utilization study is necessary to know efficacy and exhibit variations in prescribing trends and pattern of polypharmacy.Inclusion criteria includes all adult patients of either sex and who will give consent .Total about 384 prescriptions will be taken for study which will be conducted over 12months(8months for data collection and 4months for data analysis).Data will be collected after taking consent from patients. Data (drug data, demographic data and prescriber related data) will be entered in a proforma containing demographic details, clinical history ,diagnosis and treatment prescribed. Aim of study is whether Utilization and Prescription pattern of Psychotropic drugs according to standard guidelines in a rational way or not. |