| CTRI Number |
CTRI/2026/02/103354 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
“Evaluation of prescribing practices of acid-suppressing drugs in a tertiary care hospital.” |
|
Scientific Title of Study
|
An observational study on prescription pattern of various proton pump inhibitors in a tertiary health care centre. |
| 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 Anil Kumar |
| Designation |
Associate Professor |
| Affiliation |
Baba Raghav Das Medical College |
| Address |
HOD Chamber
Department of Pharmacology
Third floor
Baba Raghav Das Medical College
Gorakhpur
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
7985690200 |
| Fax |
|
| Email |
dranilk194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Agrima Mishra |
| Designation |
Junior Resident |
| Affiliation |
Baba Raghav Das Medical College |
| Address |
Department of Pharmacology
Third Floor
Academic Block
Baba Raghav Das Medical College
Gorakhpur
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
9651725776 |
| Fax |
|
| Email |
mexico.tree27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Agrima Mishra |
| Designation |
Junior Resident |
| Affiliation |
Baba Raghav Das Medical College |
| Address |
Department of Pharmacology
Third Floor
Academic Block
Baba Raghav Das Medical College
Gorakhpur
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
9651725776 |
| Fax |
|
| Email |
mexico.tree27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology
Baba Raghav Das Medical College
Gorakhpur
273013
Uttar Pradesh
INDIA |
|
|
Primary Sponsor
|
| Name |
Agrima Mishra |
| Address |
Room No T-8
100 Seated PG Girls Hostel
BRD Medical College Campus
Gorakhpur
273013
Uttar Pradesh
INDIA |
| Type of Sponsor |
Other [self] |
|
|
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 Anil Kumar |
Baba Raghav Das Medical College |
Department of Pharmacology
Gorakhpur
UTTAR PRADESH |
7985690200
dranilk194@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee Baba Raghav Das Medical College Gorakhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Adult patient more than 18 years.
Patient attending or admitted to General Medicine outpatient department during data collection period.
Patients with complete and accessible data records. |
|
| ExclusionCriteria |
| Details |
Patients less than 18 years.
Patients receiving PPI as a part of ongoing trials.
Incomplete Prescriptions.
Prescriptions with illegible handwriting.
Patients admitted for less than 24 hours. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the prescription pattern of proton pump inhibitors among patients attending a tertiary health care centre. |
At the time of enrollment during the study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the frequency of use of different proton pump inhibitors. |
During the study period. |
|
|
Target Sample Size
|
Total Sample Size="340"
Sample Size from India="340"
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)
|
18/02/2026 |
| 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 - NO
|
|
Brief Summary
|
Proton pump inhibitors (PPIs) are among the most commonly prescribed drugs for acid-related disorders and are frequently used in both inpatient and outpatient settings. Despite their proven efficacy, irrational and prolonged use of PPIs has been increasingly reported, leading to unnecessary healthcare costs and potential adverse effects. This study is an observational cross-sectional prescription pattern analysis conducted in a tertiary health care centre. The objective is to evaluate the pattern of PPI prescribing, including the frequency of use of different PPIs, their indications, dosage forms, dose and duration, and associated co-prescribed medications. The study also aims to assess the appropriateness of PPI prescriptions based on standard treatment guidelines. Data will be collected from patient prescriptions and medical records over a defined study period. The findings of this study are expected to provide insight into current prescribing practices, identify areas of irrational PPI use, and help promote rational drug use in clinical practice. |