Health Condition 1: null- Acute Exacerbation of Ulcerative Colitis
Conditions
Interventions
Intervention1: Atorvastatin: 20 mg once per day for 8 weeks
Control Intervention1: Matching Placebo: Single tablet per day for 8 weeks
Sponsors
Post Graduate Institute of Medical Eduation and Research
Eligibility
Inclusion criteria
Inclusion criteria: Patients with established diagnosis of ulcerative colitis on endoscopy Suffering from moderately severe acute ulcerative colitis having a Mayo Score between 4 to 10 at the time of enrollment despite treatment with 5-ASA Patients on stable dose of 5-ASA for the last 4 weeks Patients willing to provide written informed consent
Exclusion criteria
Exclusion criteria: Patients with severe ulcerative colitis (Mayo Score more than 11) Patients with Crohns Disease Use of immunosuppressive drugs within previous 90 days Patients with evidence of infectious colitis Patients already on lipid lowering treatment Pregnant or nursing women Patients with significant hepatic or renal disease, congestive heart failure, or any major significantly uncontrolled co-morbidity Patients who have participated in any other clinical trial during last 30 days History of allergy, hypersensitivity or any contraindications to statins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to therapy was defined as more than 1 point decrease in any 2 sub-scores of Partial Mayo Score for disease activity at any follow-up visit. Non-responders were defined as no change or less than 1 point change in any 2 subscores of Partial Mayo Scoare for disease activity at any follow-up visit. Patients with an increase of more than 1 point in any 2 sub-scores of partial Mayo were withdrawn from the study Timepoint: 0, 4 and 8 weeks after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in lipid profile from baseline Timepoint: 0, 4 and 8 weeks after randomization;Percentage of patients achieving remission defined as Mayo score of 2Timepoint: 0, 4 and 8 weeks after randomization | — |
Countries
India
Contacts
Public ContactDr Puneet Dhamija
Post Graduate Institute of Medical Education and Research
Outcome results
None listed