Ulceritive colitis. Ulcerative colitis, unspecified
Conditions
Interventions
Intervention 1: 30 mg placebo daily for 12 week. Intervention 2: Intervention:Pioglitazone 30 mg daily
for 12 week.
Placebo
Treatment - Drugs
30 mg placebo daily for 12 week
Intervention:Pioglitazone 30 mg daily
for 12 week
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) mayo score between 4 to 10 2) patients have been treated with 5-aminosalicylic acid (5-ASA) compounds at a dose of 2000 mg per day or greater for at least 4 weeks immediately prior to randomization or to have documented intolerance to such therapy.3) concomitant therapy with corticosteroids was permitted if the dose was stable for a minimum of 4 weeks prior to randomization and did not exceed prednisone 20mg per day, budesonide 9mg per day, or the equivalent. 4)Concomitant therapy with azathioprine or 6-mercaptopurine was allowed if used for a minimum of 4 months and at a stable dose for a minimum of 2 months prior to randomization.5) rectally administered corticosteroids or 5-ASA was allowed if the dose was stable for two weeks prior to randomization Exclusion criteria: 1)pregnancy breast feeding 2)stage 3 or 4 of congestive heart failure based on new york criteria 3) liver disease 4) renal failure 5) BMI>35 6) diabetic patient requiring treatment 7) colitis with other causes 8) patients with contraindications for colonoscopy 9) antidiarhial agent
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment. Timepoint: Begining/after 12 week. Method of measurement: 2 score decrease in mayo score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response to treatment. Timepoint: Begining/ after 12 week. Method of measurement: 3 score reduction in mayo score.;Quality of life. Timepoint: Begining/after 4 8 12 month. Method of measurement: Inflammatory Bowel Disease Questionnaire.;Clinical remission. Timepoint: After 12 week. Method of measurement: Mayo score.;Endoscopic remission. Timepoint: After 12 week. Method of measurement: Mayo score.;Possible side effect. Timepoint: After 4 8 12 week. Method of measurement: Patients medical records. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNaser Ebrahimi Daryani
Imam Khomeini Hospital,Tehran University of Medical Sciences
Outcome results
None listed