Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Tab Tofacitinib: Tab Tofacitinib 20 mg Once Daily per orally for 1 months followed by Tab Tofacitinib 10 mg Once daily per orally for 3 months
Sponsors
Post Graduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patient diagnosed with Ulcerative colitis 2. Patients giving willful consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1.Patient taking steroid or other biological drugs 2. Pregnant and lactating women 3. Malignancy 4. Patients with Crohn’s disease, microscopic colitis, and celiac disease 5. Patients with uncertain diagnosis 6. Patient unwilling to participate in study 7. Myocardial infarction (within previous 3 months)/Heart failure 8. Use of combined hormonal contraceptives or hormone replacement therapy 9. Patient with uncontrolled diabetes, uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To calculate mayo score, UCEIS and True love and Witt score before starting the treatment and after giving 1 month of induction followed by 3 months of maintenance dose of tofacitinib, then compare the both values.Timepoint: 1 month of induction followed by 3 months of maintenance therapy with tab Tofacitinib. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) to measure any bleeding episodes- Hematochezia during the treatment period - 4 months from initiation of treatment (2) Any hospital admission & duration of hospital stay during during the treatment period (3) Patient Satisfactory score (4) Incidences of adverse events- hyperlipidemia, Myocardial infarction, Respiratory tract infectionTimepoint: (1) to measure any bleeding episodes- Hematochezia during the treatment period - 4 months from initiation of treatment (2) Any hospital admission & duration of hospital stay during during the treatment period (3) Patient Satisfactory score (4) Incidences of adverse events- hyperlipidemia, Myocardial infarction, Respiratory tract infection | — |
Countries
India
Contacts
Public ContactDr Saroj Kant Sinha
PGIMER, Chandigarh
Outcome results
None listed