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CTRI Number  CTRI/2025/05/086960 [Registered on: 15/05/2025] Trial Registered Prospectively
Last Modified On: 14/05/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study to Understand the Awareness, Beliefs, and Practices About Food and Medicine Interactions Among Pharmacy and Medical Interns at a Major Hospital in India 
Scientific Title of Study   Awareness, Perception, and Practices of Food-Drug Interactions (FDI) among Pharmacy and Medical Interns in a Tertiary Care Teaching Hospital in India 
Trial Acronym  FDI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abdullah Yahya Ebrahim Zaawari  
Designation  PhD Research Scholar 
Affiliation  Kasturba Medical College Manipal  
Address  Ground floor, Division of Clinical Pharmacology, Department of Pharmacology, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  7981287360  
Fax    
Email  abdullah.kmcmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Jeffrey Pradeep Raj  
Designation  Associate Professor  
Affiliation  Kasturba Medical College Manipal  
Address  Ground floor, Division of Clinical Pharmacology, Department of Pharmacology, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  7904286189  
Fax    
Email  jeffrey.raj@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Jeffrey Pradeep Raj  
Designation  Associate Professor  
Affiliation  Kasturba Medical College Manipal  
Address  Ground floor, Division of Clinical Pharmacology, Department of Pharmacology, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  7904286189  
Fax    
Email  jeffrey.raj@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College Manipal, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka, India - 576104 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal  
Address  Madhav Nagar, Manipal, Udupi, Karnataka, India - 576104 
Type of Sponsor  Private 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 Abdullah Yahya Ebrahim Zaawari   Kasturba Medical College  Ground floor, Division of Clinical Pharmacology, Department of Pharmacology, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka, India - 576104
Udupi
KARNATAKA 		 7981287360

abdullah.kmcmpl2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College/Kasturba Hospital Ethics Committee -1 (KMC/KH IEC -1)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pharmacy and Medical Interns 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Pharmacy and medical interns who are currently doing internship at the hospital.
2. Willingness to participate and provide informed consent
 
 
ExclusionCriteria 
Details  1. Undergraduate students, although completed their final year, not yet in their internship phase
2. Those who are not wiling to participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Knowledge, Attitude and Practices of Food-Drug Interaction  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Association between demographic factors and KAP scores  Baseline 
 
Target Sample Size   Total Sample Size="175"
Sample Size from India="175" 
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)   01/06/2025 
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="0"
Months="3"
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  

 After obtaining Ethics Committee  approval and CTRI registration, the study will commence. The validated questionnaire will be initially piloted among 10 -15 participants. These participants will not be included in the main study. Once piloted, the questionnaire will be digitally circulated among pharmacy and medical interns through email and other messaging platforms. PIS and IC will be given on the first page. After consenting to participate, the respondent will be redirected to the questionnaire page. The questionnaire will collect information regarding awareness , perceptions and practices regarding food-drug interactions. Once the sample size is reached, the data will be gathered, cleaned, and analyzed as per the data analysis section of this protocol. After data analysis, the manuscript draft will be prepared and communicated to journals for publication.


 
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