To compare the oral steroids versus intravenous steroids as a first line therapy for treatment of Acute severe ulcerative colitis.
- Conditions
- Health Condition 1: K518- Other ulcerative colitis
- Registration Number
- CTRI/2024/03/064590
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Diagnosed cases of UC by endoscopy and biopsy
2. Patients with acute severe ulcerative colitis
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
11. Poor performance status (ECOG 3)
12. Patients with suspected or proven malignancy of any organ and GI malignancy
13. Inclusion any other drug trial in last 03 months affecting outcome of current trial
14. Not willing to participate in the trial and sign the informed consent
15. Pregnant and lactating females
16. Patients with prior colonic surgery due to any cause.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical remission (defined as stool frequency less than or equal to 3 with no blood)Timepoint: Day 3 and 6
- Secondary Outcome Measures
Name Time Method Gastrointestinal side effects of steroidTimepoint: Index admission;Number of subjects achieving Partial responseTimepoint: day 3;Requirement of second line medical therapy in both the groupsTimepoint: 3 months;Requirement of second line medical therapy in both the groups during the initial admissionTimepoint: During index admission;Requirement of surgeryTimepoint: 3 months;Requirement of surgery during the initial admissionTimepoint: During index admission;Total hospital stayTimepoint: During index admission