| CTRI Number |
CTRI/2025/06/089472 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of the pattern and percentage distribution of the types of medicines in the OP tickets issued from General Medicine OPD of Palakkad Medical College |
|
Scientific Title of Study
|
Prescription Pattern of Drugs prescribed in the Outpatient Department of General Medicine in a Tertiary Care Center in Palakkad – An Observational 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 ANSHAD YOOSEF K |
| Designation |
Postgraduate Junior Resident, MD Pharmacology |
| Affiliation |
Government Medical College Palakkad |
| Address |
Department of Pharmacology
Government Medical College Palakkad
aka Institute of Integrated Medical Sciences Palakkad
Palakkad
KERALA 678013 India |
| Phone |
9446730073 |
| Fax |
|
| Email |
anshadyoosef777@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. N Sunil |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Medical College Palakkad |
| Address |
Department of Pharmacology
Government Medical College Palakkad
aka Institute of Integrated Medical Sciences Palakkad
Palakkad
KERALA 678013 India |
| Phone |
9645666189 |
| Fax |
|
| Email |
docsunil2005@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr ANSHAD YOOSEF K |
| Designation |
Postgraduate Junior Resident, MD Pharmacology |
| Affiliation |
Government Medical College Palakkad |
| Address |
Department of Pharmacology
Government Medical College Palakkad
aka Institute of Integrated Medical Sciences Palakkad
Palakkad
Kerala
PIN 678103
KERALA 678013 India |
| Phone |
9446730073 |
| Fax |
|
| Email |
anshadyoosef777@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology and Department of General Medicine
Government Medical College Palakkad
aka Institute of Integrated Medical Sciences
East Yakkar
Kunnathurmedu PO
Palakkad
Kerala
India
PIN 678103
Ph 04912974125 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Kiran Thomas |
Government Medical College Palakkad aka Institute of Integrated Medical Sciences |
Cubicle 1
Medicine OPD
Department of General Medicine Palakkad KERALA |
9895225840
drthomasmalliyil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Integrated Medical Sciences Palakkad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, (2) ICD-10 Condition: I10||Essential (primary) hypertension, (3) ICD-10 Condition: R69||Illness, unspecified, (4) ICD-10 Condition: K279||Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation, (5) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Cases attending the General Medicine OPD
Patients belonging to any gender
Patients above the age of 18 years
Patients willing to give written informed consent
|
|
| ExclusionCriteria |
| Details |
Prescriptions containing only non-pharmacological advices
Emergency or inpatient prescriptions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Average Number of Drugs per Encounter |
12 months from the date of approval from Ethics Committee |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Commonly prescribed drug classes
Demographic distribution of patients with respect to age and gender
Polypharmacy trends and their clinical relevance
Percentage of prescriptions with the occurrence of Adverse Drug Reactions if any recorded from spontaneous patient follow-ups
Causality of the ADRs using the WHO UMC scale and NARANJO ADR scale
Severity of the ADRs using the modified Hartwig and Siegel scale
Pharmacoeconomics of the prescribed drugs with respect to the cost per prescription
|
12 months from the date of approval from Ethics Committee |
|
|
Target Sample Size
|
Total Sample Size="344" Sample Size from India="344"
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)
|
07/07/2025 |
| 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 Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anshadyoosef777@gmail.com].
- For how long will this data be available start date provided 20-07-2027 and end date provided 20-07-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A key component of
efficient healthcare delivery is the prudent use of medications which
guarantees that all patients receive the right drugs based on their clinical needs The growing population of India and rising disease rate highlight the need for
careful review of prescription procedures especially in tertiary care
facilities where a significant number of patients are admitted In order to
spot trends encourage responsible drug use and improve patient outcomes it
is essential to evaluate prescription patterns in General Medicine outpatient
departments (OPDs)
The average number of medications prescribed in each encounter the
percentage of medications provided by generic name the percentage of
prescriptions including injections the percentage of prescriptions including antibiotics
and the percentage of drugs prescribed from formularies or essential medicines
list are the basic prescribing indicators that the World Health Organization has established to assess prescription practices These metrics act as standards for
evaluating the calibre of prescribing practices and pinpointing areas that
require attention
Such prescription practices have a variety of ramifications Concurrent
use of several medications or polypharmacy increases the risk of negative
drug responses drug-drug interactions and higher medical expenses The low
prevalence of generic prescriptions raises treatment costs and may make it more
difficult for patients to follow their treatment plans Additionally antimicrobial resistance a growing public health issue in India can be
exacerbated by the improper use of antibiotics
The effectiveness of interventions meant to address these problems has
varied Over the course of three years a study conducted in central India
assessed the effects of prescription audits in conjunction with feedback
mechanisms Other prescribing trends stayed mostly the same but generic
prescribing and adherence to the National List of Essential Medicines saw a
little improvement This implies that although audit and
feedback have their uses in order to bring about significant change they
might need to be a part of a larger more comprehensive plan
Continuous monitoring and assessment are essential due to the dynamic
nature of prescribing patterns and regional disparities Knowing the current
prescription trends in tertiary care general medicine outpatient departments can help guide focused initiatives encourage responsible drug use and
improve patient outcomes In order to identify areas for
improvement and add to the body of knowledge already available on rational drug
use this study intends to evaluate the prescribing trends in the General Medicine
outpatient department of Government Medical College Palakkad which is a tertiary care
center in India using the WHO prescribing indicators
Prescription pattern analysis helps to determine the degree of
polypharmacy the current trend of prescriptions the demographic distribution
of patients receiving drugs the presence of adverse drug reactions and
drug drug interactions There are only a few studies on the drug prescribing
patterns in the General Medicine outpatient departments in Kerala Therefore this study is crucial to address the gaps in the literature on this topic |