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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anshadyoosef777@gmail.com].

  6. 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.

  7. 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

 
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