| CTRI Number |
CTRI/2024/09/074071 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Appropriateness of drugs used for reduction of gastric acid secretion in teaching hospital:A study that follows a group of people over time to see how things change or develop. |
|
Scientific Title of Study
|
Drug utilization evaluation of proton pump inhibitors in teaching hospital: A Prospective- longitudinal 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 |
Mohammed Adeeb |
| Designation |
Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
8971861530 |
| Fax |
|
| Email |
adeebm369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammed Adeeb |
| Designation |
Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
8971861530 |
| Fax |
|
| Email |
adeebm369@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammed Salim KT |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9656798071 |
| Fax |
|
| Email |
salim.kt@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
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 Mohammed Salim KT |
Department of General medicine, Kasturba Hospital |
Department of General Medicine, unit 6 - room number 18, Udupi- Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9656798071
salim.kt@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z538||Procedure and treatment not carried out for other reasons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients prescribed with Proton Pump Inhibitors |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Terminally ill patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of PPI prescribed at higher dose, frequency of drug interactions and ADRs associated with PPIs. Adherence to PPI deprescribing guidelines. |
48 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adherence to PPI deprescribing guidelines. |
48 weeks |
|
|
Target Sample Size
|
Total Sample Size="296"
Sample Size from India="296"
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)
|
01/10/2024 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A prospective longitudinal study will be conducted at the Department of General Medicine. A literature review will be conducted followed by development of a Case Report Form. Upon receiving IEC approval, the Informed Consent (IC) and Patient Information Sheet (PIS) forms are prepared. With the necessary ethical approvals and consent forms in place, the data collection phase begins. This phase involves gathering both initial baseline data and follow-up data from participants. The next step involves assessing and identification of ADRs and detailed causality and severity assessment. The need for Deprescribing will be evaluated as per guidelines. |