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Clinical Trials/CTRI/2024/12/077824
CTRI/2024/12/077824
Not yet recruiting
Not Applicable

Evolution Of Endoscopic Lesions And Histological Indices In Cases Of Severe And Moderate Ulcerative Colitis

Institute of Post Graduate Medical Education and Research1 site in 1 country368 target enrollmentStarted: December 17, 2024Last updated:
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Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Institute of Post Graduate Medical Education and Research
Enrollment
368
Locations
1
Primary Endpoint
To study the time course of Clinical and Endoscopic Scores following the baseline presentation in moderate and severe UC patients
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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

Study Design

Study Type
Observational

Eligibility Criteria

Ages
12.00 Year(s) to 59.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

To study the time course of Clinical and Endoscopic Scores following the baseline presentation in moderate and severe UC patients

Time Frame: To study the time course at first presentation then at 6 weeks then at 6 months

Secondary Outcomes

  • 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)

Investigators

Sponsor
Institute of Post Graduate Medical Education and Research
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Soham Bhaumik

Institute of Post Graduate Medical Education and Research

Study Sites (1)

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