FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064842 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational intervention to residents doctors regarding ppi use]  
Study Design  Other 
Public Title of Study   EDUCATIONAL INTERVENTION TO IMPROVE PRESCRIBING HABITS OF DOCTORS IN THE TREATMENT OF ACID RELATED DISORDERS  
Scientific Title of Study   Impact of professional education on relevant use of Proton pump inhibitors in a tertiary care hospital 
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 Amog Bude 
Designation  Junior Resident  
Affiliation  GOA MEDICAL COLLEGE & HOSPITAL 
Address  Department of Pharmacology, Goa Medical College, Bambolim tiswadi - Goa
Bambolim, Goa
North Goa
GOA
403202
India 
Phone  9096255541  
Fax    
Email  amogbudea2b@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SUNITA DE SA  
Designation  ASSOCIATE PROFESSOR  
Affiliation  GOA MEDICAL COLLEGE & HOSPITAL 
Address  Department of Pharmacology, Goa Medical College, Bambolim tiswadi - Goa
Bambolim, Goa
North Goa
GOA
403202
India 
Phone  9850452364  
Fax    
Email  sunitadesa02@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amog Bude 
Designation  Junior Resident  
Affiliation  GOA MEDICAL COLLEGE & HOSPITAL 
Address  Department of Pharmacology, Goa Medical College, Bambolim tiswadi - Goa
Bambolim, Goa
North Goa
GOA
403202
India 
Phone  9096255541  
Fax    
Email  amogbudea2b@gmail.com  
 
Source of Monetary or Material Support  
GOA MEDICAL COLLEGE, BAMBOLIM GOA  
 
Primary Sponsor  
Name  Goa Medical College & Hospital 
Address  Bambolim, tiswadi - Goa 403202 
Type of Sponsor  Government medical college 
 
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 AMOG BUDE  GOA MEDICAL COLLGE.   OUT PATIENT Departments of surgery and medicine.
North Goa
GOA 
09096255541

amogbudea2b@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GOA MEDICAL COLLGE INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EDUCATIONAL INTERVATION ON RELEVANT USE OF PPIs  COMPILATION OF GUIDELINES GIVEN BY AMERICAN SOCIETY OF GASTROENTEROLOGY, AMERICAN COLLGE OF GASTROENTEROLOGY ON DISEASE MANAGEMENT AND USE OF PROTON PUMP INHIBITORS. The intervention phase will be carried out for 2 months , educating all junior residents in the departments of medicine & surgery 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ALL PRESCRIPTIONS OF PATIENTS BETWEEN AGE GROUP OF 18-60 YEARS WRITTEN BY JUNIOR RESIDENTS IN SURGERY AND MEDICINE DEPARTMENTS OPDs. 
 
ExclusionCriteria 
Details  PREGNANT WOMEN 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rational prescription of Proton pump inhibitors by JUNIOR RESIDENT DOCTORS  Till sample size is reached  
 
Secondary Outcome  
Outcome  TimePoints 
drug interactions caused with proton pump inhibitors   same as duration of study 
 
Target Sample Size   Total Sample Size="640"
Sample Size from India="640" 
Final Enrollment numbers achieved (Total)= "640"
Final Enrollment numbers achieved (India)="640" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) 30/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

IMPACT OF PROFESSIONAL EDUCATION ON RELEVANT USE OF PROTON PUMP INHIBITORS IN TERTIARY CARE HOSPITAL.

INTRODUCTION

Proton pump inhibitors (PPIs) are among the most commonly prescribed drugs for various acid-related gastrointestinal (GI) disorders in healthcare systems. Guidelines and recommendations for the use of PPIs in different clinical conditions have been published. Despite the availability of guidelines, non-judicious use of these drugs has been reported in several studies. In this context of potential overprescription and additional costs for society, a professional education intervention is intended. 

BACKGROUND & RATIONALE : 

Proton pumps in gastric parietal cells carry out the last step of acid secretory pathway. Proton pump inhibitors were widely accepted as they had excellent safety and efficacy profile in acid suppression. Recently Several study have demonstrated overprescription and non judicious use of this drugs leading to additional cost to society. Also some recent studies links chronic, non judicious use of these drugs to several adverse effects. This study aims towards promoting rational prescription of proton pump inhibitors among Resident doctors in a tertiary care hospital.  

 

AIMS & OBJECTIVES

Primary objectives

1.    To study the prescription pattern of PPI in Medicine & Surgery Department.

2.    To study the impact of professional education on relevant use of Proton pump inhibitors.

Secondary objectives

           To study potential drug interactions with PPIs

 

 

 

MATERIAL & METHODS

The study will be conducted in two phases. In the first phase, prescription pattern data will be collected from the medicine and surgery OPDs. During the intervention phase, Junior Resident doctors from both the surgery and medicine departments will be informed about the relevance of their prescriptions in accordance with current recommendations. Additionally, the distribution of prescription aid leaflets will be carried out with the aim of improving practices. Subsequently, in the second phase, the prescription pattern of PPI use will be re-evaluated.

Intervention: Educational intervention with leaflets and digital pamphlets regarding relevant drug prescriptions, which will comprise guidelines for disease management and information regarding drugs, dosage, duration, and schedule of therapy, will be provided to Junior Residents in the medicine and surgery departments.

 

Phase 1 : Pre – Intervention

 

EDUCATIONAL INTERVENTION

( To Junior Resident doctors )

Phase 2 : Post – Intervention

 

 

 

SAMPLING

Sample size  : ( By COCHRAN’S formula )

P=0.27, q=0.73, Z=1.96 and d=0.05

Phase 1: 320 , Phase 2 :  320

Sampling method : Simple random sampling

 

ELIGIBILITY

Inclusion criteria:

"All patients’ prescriptions between the ages of 18 and 60 years from the outpatient departments (OPDs) of the Medicine and Surgery Departments, prescribed by junior resident doctors."

Exclusion criteria:

Pregnant women will be excluded from study.

 

DATA COLLECTION

Data will be collected from OPD case papers of patients visiting Medicine and surgery OPDs and transcribed into proformas.

 

 Data Collection Proforma

 

Patient’s hospital ID :

Age:

Sex:

Date:

Department:

Diagnosis ( if mentioned )

Indication for Use of PPI:

Sr. No.

Drugs

Dose

Duration of therapy

Route

Frequency

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 
Close