FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/06/043271 [Registered on: 15/06/2022] Trial Registered Prospectively
Last Modified On: 14/06/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Knowledge of Inflammatory Bowel Disease (IBD) among the students of Manipal Academy of Higher Education, Manipal India 
Scientific Title of Study   Knowledge of Inflammatory Bowel Disease among the students of MAHE, Manipal MAHE, Manipal India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shailesh 
Designation  Senior Research Fellow 
Affiliation  Kasturba Medical College 
Address  Dept. of Gastroenterology and Hepatology, Kasturba Medical College, Manipal 576104 Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  7406985507  
Fax    
Email  shailesh.kmc@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Shailesh 
Designation  Senior Research Fellow 
Affiliation  Kasturba Medical College 
Address  Dept. of Gastroenterology and Hepatology, Kasturba Medical College, Manipal 576104 Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  7406985507  
Fax    
Email  shailesh.kmc@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Shailesh 
Designation  Senior Research Fellow 
Affiliation  Kasturba Medical College 
Address  Dept. of Gastroenterology and Hepatology, Kasturba Medical College, Manipal 576104 Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  7406985507  
Fax    
Email  shailesh.kmc@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal 576104 
 
Primary Sponsor  
Name  Shailesh 
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal 
Type of Sponsor  Other [Self] 
 
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 Ganesh Pai C  Manipal Academy of Higher Education  4th floor New OPD, (Room No 1) Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA 		 08202922192

gastro.kmc@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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No exclusions 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Currently a student at constituent institutes/ colleges of Manipal Academy of Higher Education 
 
ExclusionCriteria 
Details  Not willing to give the consent for the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Assess the knowledge about IBD using the self-administered questionnaire containing 15
questions 		 Baseline (one time point only) 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="864"
Sample Size from India="864" 
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)   17/06/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/06/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The extent of public knowledge about IBD in India is obscure, as it is considered as a western disease. But the prevalence and incidence rate of IBD in India is increasing, topping the Southeast Asian nations. The students’ evaluation of awareness levels will offer a description of where the general perception lies and where the shortcoming exists, that could be addressed to reduce public stigma and increase community support for IBD patients. Thus the aim of the study is to implement a validated knowledge survey (IBD-KID2) in students of MAHE, Manipal to establish the level of knowledge about IBD in the studied population. 
Close