A clinical trial to compare the effects of corticosteroid at different dosage and duration in patient of active Ulcerative Colitis disease

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2021
INTERVENTION: Intervention1: Prednisolone: Oral prednisolone 40 mg initially will continued for 2 weeks thereafter will be tapered 10 mg weekly till 6 weeks followed by matching placebo for 4 weeks in short taper arm (STA). Control Intervention1: Prednisolone: Oral prednisolone 40 mg initially will continued for 2 weeks thereafter will be tapered 5mg weekly till 9th week and 2.5 mg taper in the last week making total duration 10 weeks in long taper arm (LTA) CONDITION: Health Condition 1: K519‐ Ulcerative colitis, unspecified PRIMARY OUTCOME: To compare the rates of disease remission after six months of steroid initiation by Mayo score.Timepoint: Baseline and 6 months SECONDARY OUTCOME: 1. To compare safety of steroid tapering regimen in ulcerative colitis patients ; 2. To compare the changes in fecal microbiome ; 3. To compare mucosal healing by UCEIS scoring system ; 4. To compare Histologic changes by Nancy Index scoring systemTimepoint: Safety: Baseline, 3 months and 6 months ; Fecal Microbiome: Baseline, 3 months and 6 months ; UCEIS score: Baseline and 6 months ; Nancy index score: Baseline and 6 months INCLUSION CRITERIA: 1. Evidence of active ulcerative colitis as defined by the Mayo score of > 2 (with endoscopic score of at‐least 2) 2. Initiated on steroids for disease activity as per clinicians judgement 3. Evidence of clinical response to steroids, as evidenced by reduction in stool frequency (reduction by 50%) with disappearance (or marked reduction) of visible blood by 2 weeks
Epistemonikos ID: 0f35c415d8472ca6d6ece4fdfa0e5d61a9ef7c60
First added on: Mar 23, 2022