| CTRI Number |
CTRI/2026/04/109099 [Registered on: 22/04/2026] Trial Registered Prospectively |
| Last Modified On: |
29/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prescription study & use of Acid -Reducing Medicines (PPIs) among patients attending tertiary care hospital |
|
Scientific Title of Study
|
Utilisation of Proton Pump Inhibitors In Outpatients At A Tertiary Care Hospital In Central India: A Pharmacoepidemiological 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 Anjali Soni |
| Designation |
PG Resident |
| Affiliation |
Chhattisgarh Institute of Medical Sciences Bilaspur |
| Address |
Department of Pharmacology, 2nd floor, CIMS, Bilaspur
Bilaspur
CHHATTISGARH
495001
India |
| Phone |
8839793853 |
| Fax |
|
| Email |
anjalisoniofficial00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreya Todi |
| Designation |
Professor & HOD |
| Affiliation |
Chhattisgarh Institute of Medical Sciences Bilaspur |
| Address |
Department of Pharmacology,CIMS, Bilaspur (C.G)
Bilaspur
CHHATTISGARH
495001
India |
| Phone |
8337011511 |
| Fax |
|
| Email |
todi.sreya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Soni |
| Designation |
PG Resident |
| Affiliation |
Chhattisgarh Institute of Medical Sciences Bilaspur |
| Address |
Department of Pharmacology, 2nd floor CIMS Bilaspur (C.G)
Bilaspur
CHHATTISGARH
495001
India |
| Phone |
8839793853 |
| Fax |
|
| Email |
anjalisoniofficial00@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anjali Soni |
| Address |
Pharmacology department,2nd floor CIMS, Bilaspur (C.G)
Pincode -495001 |
| 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 Anjali Soni |
Chhattisgarh Institute of Medical Sciences |
Department of Pharmacology, 2nd floor,CIMS,Bilaspur
Bilaspur
CHHATTISGARH |
8839793853
anjalisoniofficial00@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,CIMS, Bilaspur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give informed consent, of either sex aged greater than 18 years & who has been prescribed atleast one oral proton pump inhibitors in their prescription. |
|
| ExclusionCriteria |
| Details |
Incomplete or Illegible prescription, Emergency prescriptions & any patients who has been prescribed parenteral Proton Pump Inhibitors |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Auditing prescriptions of various departments of CIMS, Bilaspur for PPI prescribing patterns & rationality using CDSCO & NICE Guidelines |
20 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Most commonly prescribed PPI agents & their dosage regimens |
20 weeks |
| Analyze demographic profiles of patients receiving PPI therapy |
20 weeks |
| Audit prescriptions according to NHM Criteria |
20 weeks |
| Study the prescriptions for any possible drug-drug interactions using Medscape & Micromedex drug interaction checker |
20 weeks |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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)
|
25/05/2026 |
| 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 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
|
Proton Pump Inhibitors have high prescription rate & are commonly used as Gastro protective agents, highlighting their significance in Indian healthcare. However, addressing concerns about appropriate usage & potential drug interactions is crucial to ensure optimal patient care & reduce unnecessary costs. It will also help the clinician to know about these drugs as there are very less studies done in Chhattisgarh. |