| CTRI Number |
CTRI/2025/07/091689 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating opportunities for dose reduction or discontinuation of proton pump inhibitors in older adults using deprescribing criteria, with recommendations provided to physicians, and assess their willingness to accept |
|
Scientific Title of Study
|
Evaluating deprescribing opportunities of proton pump inhibitors in older adults and physicians readiness to accept the related recommendations |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IECKMCMLR05/2025/248 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hrishikesh K S |
| Designation |
Postgraduate |
| Affiliation |
Kasturba Medical College, Manglore |
| Address |
Department of Pharmacology, Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8281721032 |
| Fax |
|
| Email |
hrishikesh.kmcmlr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rashmi R Rao |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manglore |
| Address |
Department of Pharmacology, Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8971401840 |
| Fax |
|
| Email |
rashmi.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hrishikesh K S |
| Designation |
Postgraduate |
| Affiliation |
Kasturba Medical College, Manglore |
| Address |
Department of Pharmacology, Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8281721032 |
| Fax |
|
| Email |
hrishikesh.kmcmlr2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
203, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka 575001 |
|
|
Primary Sponsor
|
| Name |
Dr Hrishikesh K S |
| Address |
Department of Pharmacology, Kasturba Medical College, Mangalore, Dakshina Kannada, Karnataka, India-575001 |
| 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 Hrishikesh K S |
Kasturba medical college hospital Attavar |
Department of general medicine, Nandigudda Rd, Attavar, Mangaluru, Karnataka 575002
Dakshina Kannada
KARNATAKA |
08281721032
hrishikesh.kmcmlr2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Kasturba Medical College Manglore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K297||Gastritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged 60 years and above who are admitted to the hospital ward for any indication during the period from July 2025-December 2026 and prescribed proton pump inhibitors by oral or parenteral route
Willingness to give informed consen |
|
| ExclusionCriteria |
| Details |
Patients admitted to ICU or critically ill.
Patients with severe communication disorders or dementia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The number of patients who meet the criteria for deprescribing proton pump inhibitors based on the standard criteria, to know the difference in clinical characteristics of those with and without deprescribing recommendation and to assess the physicians’ acceptance of deprescribing recommendations. |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
07/08/2025 |
| 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="6"
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
|
This is a hospital-based observational study for evaluating opportunities of deprescribing proton pump inhibitors in older adults and the response of physicians to the related recommendations. It will be conducted to hospitals affiliated with Kasturba Medical College, Mangalore. The primary outcome measures the number of patients who meet the criteria for deprescribing proton pump inhibitors based on the standard criteria, to know the difference in clinical characteristics of those with and without deprescribing recommendation and to assess the physicians’ acceptance of deprescribing recommendations. |