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CTRI Number  CTRI/2024/08/072267 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Assessment of a newer teaching method]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of knowledge gained using newer versus lecture based teaching method on antimicrobial education among second year MBBS students 
Scientific Title of Study   Randomized comparative study of novel teaching-learning methods versus conventional pedagogy in educating phase II MBBS students on different aspects of antimicrobial use 
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 Tushar Chauhan 
Designation  Junior Resident 
Affiliation  Government Medical College Patiala 
Address  Department of Pharmacology, Government Medical College, Patiala, Punjab

Patiala
PUNJAB
147001
India 
Phone  8279695395  
Fax    
Email  drchauhantushar1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Navjot Kaur 
Designation  Associate Professor 
Affiliation  Government Medical College Patiala 
Address  Department of Pharmacology, Government Medical College, Patiala, Punjab

Patiala
PUNJAB
147001
India 
Phone  9478610996  
Fax    
Email  drnavjotpharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tushar Chauhan 
Designation  Junior Resident 
Affiliation  Government Medical College Patiala 
Address  Department of Pharmacology, Government Medical College, Patiala, Punjab


PUNJAB
147001
India 
Phone  8279695395  
Fax    
Email  drchauhantushar1996@gmail.com  
 
Source of Monetary or Material Support  
Department of Pharmacology, Government Medical College and Rajindra Hospital, Patiala, Pin code- 147001, Punjab, India.  
 
Primary Sponsor  
Name  Department of Pharmacology GMC Patiala 
Address  Department of Pharmacology, Government Medical College and Rajindra Hospital, Patiala, Pin code- 147001, Punjab, India. 
Type of Sponsor  Government 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 Tushar Chauhan  Government Medical College and Rajindra Hospital Patiala  Lecture Theatre, Department of Pharmacology.
Patiala
PUNJAB 		 8279695395

drchauhantushar1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (IEC) Government Medical College Patiala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Phase II MBBS Students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional teaching method   Topic will be taught using lecture technique during the scheduled teaching time (approx. 1 hour) on the day of conduct of study among phase II MBBS students. 
Intervention  Newer teaching methods  Topic will be taught using interactive games during the scheduled teaching time (approx. 1 hour) on the day of conduct of study among phase II MBBS students. 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  22.00 Year(s)
Gender  Both 
Details  Phase II MBBS students who will give consent to participate in the study. 
 
ExclusionCriteria 
Details  1. Phase II MBBS students who refuse to participate in the study.
2. Phase II MBBS students who remain absent on the day of study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the knowledge gained on different aspects of antimicrobial use among phase II MBBS students by novel teaching-learning methods versus conventional pedagogy.  Pre intervention test and post intervention test on same day and after 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the feedback of phase II MBBS students regarding novel teaching-learning methods.  On the day of intervention 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="230" 
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   Phase 4 
Date of First Enrollment (India)   18/08/2024 
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="0"
Days="15" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response (Others) -  Purely for academic purposes

  5. By what mechanism will data be made available?
    Response (Others) -  on reasonable request to corresponding author solely for academic purposes eg. individual participant data based metaanalysis of similar kind of studies

  6. For how long will this data be available start date provided 15-02-2025 and end date provided 15-05-2025?
    Response (Others) -  15-02-2025 to 15-05-2025

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

A randomized comparative study will be conducted among the phase II MBBS students after obtaining approval from the Institute Ethics Committee. After receiving written informed consent, the students will be randomly allocated to one of two groups: control group (using conventional pedagogy i.e. didactic lecture-based learning) or experimental group (using novel teaching-learning methods). A pretest will be administered to both the groups to have baseline assessment of the knowledge of the topic. After completion of respective teaching-learning sessions, a post-test (immediately and 15 days after the session) will be administered and scores will be calculated. In addition, students’ feedback regarding novel teaching-learning methods will be obtained with the help of a post intervention survey. Data will be analysed using descriptive statistics and student’s t-test wherever appropriate.

 
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