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Clinical Trials/CTRI/2024/03/064590
CTRI/2024/03/064590
Not yet recruiting
Phase 3

To study the efficacy of oral corticosteroid compared to intravenous corticosteroid as a first line therapy for treatment of Acute severe ulcerative colitis. - NI

PGIMER0 sites0 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
PGIMER
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
PGIMER

Eligibility Criteria

Inclusion Criteria

  • •1\. Diagnosed cases of UC by endoscopy and biopsy
  • •2\. Patients with acute severe ulcerative colitis

Exclusion Criteria

  • •1\. Patients with Hb less than 8g/dl
  • •2\. Patients with serum albumin levels less than 2\.5 g/dl
  • •3\. Patients with sepsis precluding the use of corticosteroids with any two of the three criteria Fever Temp more than 100 F, TLC less than 4000/cumm or more than 12000/cumm, raised procalcitonin (more than 1 pg/dL)
  • •4\. Patients having more than 10 blood mixed stools
  • •5\. Patients having megacolon or toxic megacolon on abdominal x\-ray
  • •6\. Patients with abdominal tenderness or features of impending perforation
  • •7\. Patients who have had any flare requiring corticosteroids in the preceding 3 months from inclusion
  • •8\. Patients with prior history of failure of response to intravenous corticosteroids for severe flare of ulcerative colitis
  • •9\. Patients already receiving oral corticosteroid at the time of inclusion
  • •10\. Patient who have received more than 1 dose of IV Corticosteroid during index admission

Outcomes

Primary Outcomes

Not specified

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