Periappendiceal injection of steroids in ulcerative colitis
- Registration Number
- CTRI/2012/04/002605
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
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
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 < 9 g/dL), leukopenia, thrombocytopenia, or abnormal coagulation;
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical activity index (CAI) and endoscopic index (EI)Timepoint: Clinical activity index (CAI) will be measured at entry (within 2 weeks before <br/ ><br>randomization), every 2 months, and then at the conclusion of the clinical trial, whereas <br/ ><br>endoscopic index (EI) will be determined at entry and at the conclusion of the trial.
- Secondary Outcome Measures
Name Time Method Inflammatory cytokine profileTimepoint: 3 month after injection of steroids and during relapse