Treatment of patients with ulcerative colitis
Not Applicable
- Conditions
- Health Condition 1: null- Ulcerative ColitisHealth Condition 2: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2020/06/025914
- Lead Sponsor
- Department of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
1.Age < 18 years, >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>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. <br/ ><br>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 Outcome Measures
Name Time Method ilTimepoint: Nil