None listed
Conditions
Interventions
Intervention1: Periappendiceal injection (80 mg) of triamcinolone: Injection is to be given Periappendiceally through the colonoscope only once at the initial colonoscopy
Control Intervention1: Placeb
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: a. Male or female patients 18 years of age or older with an established diagnosis of IUC b. In clinical remission for at least 3 months on 5-ASA at a stable dose ranging from 1.6 to 2.4 g/day c. Patient had achieved remission with a corticosteroid > 20 mg/day prednisolone or an alternative medication and had successfully ceased steroid therapy d. Patients undergoing colonoscopy for assessment of the extent of the disease
Exclusion criteria
Exclusion criteria: a. Patients on immunomodulators like azathioprine, 6 mercaptopurine and mycophenolate mofetil b. Patients with severe cardiovascular diseases c. Patients with laboratory abnormalities indicating anemia (hemoglobin d. Patients with renal or liver disease, chronic pancreatitis, diabetes mellitus, mental disorders or gallstone e. Patients with infection, sepsis, or pneumonia f. Pregnant or nursing women. g. History of appendectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical activity index (CAI) and endoscopic index (EI)Timepoint: Clinical activity index (CAI) will be measured at entry (within 2 weeks before randomization), every 2 months, and then at the conclusion of the clinical trial, whereas endoscopic index (EI) will be determined at entry and at the conclusion of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory cytokine profileTimepoint: 3 month after injection of steroids and during relapse | — |
Countries
India
Contacts
Public ContactDr Surinder Rana
PGIMER, Chandigarh
Outcome results
None listed