Health Condition 1: null- Ulcerative Colitis Health Condition 2: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Intervention group: The intervention group will be started on steroid course of 12 weeks ( Route is oral, frequency once daily, 40mg tapered every week as per clinical improvement by 5m
Sponsors
Department of Gastroenterology
Funding not required
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of active ulcerative colitis presenting within 1 year of disease onset. 2.Patients with left sided or pancolitis. 3.Patients who have not received any dose of steroid, immune-modulators or biologics. 4.Patient giving written informed consent.
Exclusion criteria
Exclusion criteria: 1.Age 75 years. 2.Patients with only rectal involvement (E1 disease). 3.Patients presenting with acute severe ulcerative colitis requiring hospitalization. 4.Patients with indeterminate form of colitis. 5.Pregnancy • Patient with concomitant gastrointestinal infection. • Patients infected with HBV, HCV or HIV. • Other major co-morbid conditions like acute myocardial infarction, chronic kidney disease or chronic liver disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients who will achieve deep remission at 12 weeks (subgroup A) will be continued on 5- ASA with dose adjustment and topical therapy as needed and be followed up for 18 months. Partial responders at 12 weeks (Subgroup B) will be started on azathioprine in addition. These patients will be evaluated at 24 weeks for deep remission. Patients who will achieve deep remission will be followed up for 18 months with periodic biochemical and endoscopic evaluation.Timepoint: Patients who will achieve deep remission at 12 weeks (subgroup A) will be continued on 5- ASA with dose adjustment and topical therapy as needed and be followed up for 18 months. Partial responders at 12 weeks (Subgroup B) will be started on azathioprine in addition. These patients will be evaluated at 24 weeks for deep remission. Patients who will achieve deep remission will be followed up for 18 months with periodic biochemical and endoscopic evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Pabitra Sahu
Dept of Gastroenterology, AIIMS
Outcome results
None listed