| CTRI Number |
CTRI/2024/12/077824 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
In Cases Of Severe And Moderate Ulcerative Colitis patients endoscopic and histological changes to be evaluated at first presentation 6 weeks and 6 months and correlation among these changes
|
|
Scientific Title of Study
|
Evolution Of Endoscopic Lesions And Histological Indices In Cases Of Severe And Moderate 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 |
Soham Bhaumik |
| Designation |
MEDICAL GASTROENTEROLOGY DM RESIDENT |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
RONALD ROSS BUILDING 5TH FLOOR
SCHOOL OF DIGESTIVE AND LIVER DISEASE
DEPARTMENT OF GASTROENTEROLOGY
Institute of Post Graduate Medical Education and Research District KOLKATA
54 RASHBIHARI SARANI HAKIMPARA SILIGURI
Darjiling
WEST BENGAL
700020
India |
| Phone |
8910442298 |
| Fax |
|
| Email |
sohambhaumik1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajib Sarkar |
| Designation |
Associate Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
RONALD ROSS BUILDING 5TH FLOOR
SCHOOL OF DIGESTIVE AND LIVER DISEASE
DEPARTMENT OF GASTROENTEROLOGY
Institute of Post Graduate Medical Education and Research DISTRICT KOLKATA
Subhaspally
Madhyamgram
North Twentyfour Parganas
WEST BENGAL
700020
India |
| Phone |
9477371103 |
| Fax |
|
| Email |
rajjoy5661@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soham Bhaumik |
| Designation |
MEDICAL GASTROENTEROLOGY DM RESIDENT |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
RONALD ROSS-5TH FLOOR
SCHOOL OF DIGESTIVE AND LIVER DISEASE
DEPARTMENT OF GASTROENTEROLOGY
Institute of Post Graduate Medical Education and Research DISTRICT-KOLKATA
54 RASHBIHARI SARANI HAKIMPARA SILIGURI
Darjiling
WEST BENGAL
700020
India |
| Phone |
8910442298 |
| Fax |
|
| Email |
sohambhaumik1990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Medical Education and Research |
| Address |
RONALD ROSS BUILDING 5TH FLOOR
SCHOOL OF DIGESTIVE AND LIVER DISEASE
IPGMER AND SSKM HOSPITAL
KOLKATA 20 |
| Type of Sponsor |
Government medical college |
|
|
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 Soham Bhaumik |
Institute of Post Graduate Medical Education and Research |
RONALD ROSS BUILDING 5TH FLOOR
SCHOOL OF DIGESTIVE AND LIVER DISEASE
DEPARTMENT OF GASTROENTEROLOGY
244 AJC BOSE ROAD KOLKATA 700020
Kolkata
WEST BENGAL |
8910442298
sohambhaumik1990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,IPGMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K518||Other ulcerative colitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Acute Severe ulcerative colitis who fulfil the Truelove and Witts criteria
Moderate and Severe ulcerative Colitis according to PMS Score or Mayo Score
Patients started on immunomodulators Azathioprine Infliximab Tofacitinib less than 6 weeks before inclusion
Patients who give consent to comply with follow up investigations and the treatment schedule
|
|
| ExclusionCriteria |
| Details |
Acute severe Ulcerative Colitis who required Colectomy in their index presentation
Loss of follow up
Patients with contraindications to all the three drugs-Azathioprine Infliximab and tofacitinib
Patients who do not give consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the time course of Clinical and Endoscopic Scores following the baseline presentation in moderate and severe UC patients |
To study the time course at first presentation then at 6 weeks then at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the time course of Histological Index following the baseline presentation
To correlate among the Clinical Endoscopic & Histological scores over the given time period
To determine the predictors of relapse at 6 months following index presentation of this cohort of UC patients
|
To study the time course at first presentation then at 6 weeks then at 6 months |
|
|
Target Sample Size
|
Total Sample Size="368"
Sample Size from India="368"
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)
|
17/12/2024 |
| 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="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
|
In
this study we will assess the baseline clinical severity and mucosal
involvement using endoscopy and histology in patients of Severe
and Moderate Ulcerative Colitis at baseline and reassess
the Endoscopic and Histological activity achieved at the end of 6 weeks and 6
months by using the composite score of validated Endoscopic scores and
Histologic Indices in School of Digestive and Liver Disease Department of
Gastroenterology IPGMER & SSKM Hospital
|