FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/081815 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To compare various scores and parameters to predict steroid failure of patients with acute severe ulcerative colitis 
Scientific Title of Study   Comparison of severity scores in predicting non-response to steroids in acute severe ulcerative colitis 
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 Keval Vora 
Designation  Senior resident 
Affiliation  GB Pant institute of postgraduate medical education and research 
Address  Academic block second floor, Department of Gastroenterology, Govind Ballabh Pant institute of postgraduate medical education and research

New Delhi
DELHI
110002
India 
Phone  9033325199  
Fax    
Email  kevvalrvora@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Dalal 
Designation  Associate Professor 
Affiliation  GB Pant institute of postgraduate medical education and research 
Address  Academic block second floor, Department of Gastroenterology, Govind Ballabh Pant institute of postgraduate medical education and research

New Delhi
DELHI
110002
India 
Phone  9718599219  
Fax    
Email  ashok.dalal83@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Dalal 
Designation  Associate Professor 
Affiliation  GB Pant institute of postgraduate medical education and research 
Address  Academic block second floor, Department of Gastroenterology, Govind Ballabh Pant institute of postgraduate medical education and research

New Delhi
DELHI
110002
India 
Phone  9718599219  
Fax    
Email  ashok.dalal83@gmail.com  
 
Source of Monetary or Material Support  
Govind Ballabh Pant institute of postgraduate Medical education and research 
 
Primary Sponsor  
Name  Govind Ballabh Pant institute of postgraduate Medical education and research 
Address  Jawahar lal Nehru marg New Delhi-110002  
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 Keval Vora  Govind Ballabh Pant institute of postgraduate Medical education and research  Academic block second floor, Department of Gastroenterology, Govind Ballabh Pant institute of postgraduate medical education and research
New Delhi
DELHI 		 9033325199

kevvalrvora@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana Azad Medical College And Associated Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K510||Ulcerative (chronic) pancolitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with acute severe ulcerative colitis defined by truelove and witts criteria 
 
ExclusionCriteria 
Details  Pregnant
Colorectal malignancy
Previous surgical resection
Serious complications such as infections , intestinal tuberculosis and ischemia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Compare various scores and parameters predicting steroid non-response in ASUC  during ASUC 
 
Secondary Outcome  
Outcome  TimePoints 
To compare various scores and parameters predicting patients requiring colectomy
To compare various scores and parameters predicting patients requiring rescue therapy 		 during ASUC 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/04/2025 
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="1"
Months="6"
Days="0" 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kevvalrvora@gmail.com].

  6. For how long will this data be available start date provided 13-09-2025 and end date provided 13-09-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Ours is a cross sectional single center study in which patients with diagnosed acute severe ulcerative colitis by truelove and Witts criteria will be enrolled. Patients will undergo routine blood investigations, CRP , Stool examinations, Abdominal xrays, flexible sigmoidoscopy and USG for colonic wall thickness. Various scores will be included from this information and compared with outcome of ASUC which will be either remission, colectomy or rescue therapy.  
Close