Role of Roflumilast in Ulcerative Colitis
Ulcerative Colitis
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria: Patients referred to endoscopy units in Tanta University hospitals during the period of the study. Patient with mild to moderate UC diagnosed as: Clinical signs: Patients with moderate clinical disease have frequent loose, bloody stools (>4per day), mild anemia, and abdominal pain that is not severe. Patients have minimal signs of systemic toxicity, including a low-grade fever. Adequate nutrition is usually maintained, and weight loss. Endoscopy : are necessary to establish the chronicity of inflammation and to exclude other causes of colitis. Exclusion Criteria: Other inflammatory bowel disease (crohn's disease) . Patients <15 and >80 years Patients who didn't give consent to participate in the study Patients with contraindications of colonoscopy e.g. suspected colonic perforation, acute peritonitis, pregnancy, severe bleeding tendency, shock, uncooperative patient and if toxic mega colon is suspected were excluded History of allergic reaction to Roflumilast or any component of the formulation Like rash , hives ,itching and redness . Depression , thoughts of suicide , anxiety and emotional instability . Excessive weight loss . Moderate to severe hepatic impairment (child pugh class B or C) . Strong (CYP3A4) inducers : Barbiturates (phenobarbital) , Carbamazepine , Phenytoin , Rifampicin ( Risk , X interaction ) Loxapine ( Risk , X interaction )
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
conventional treatment group
experimental treatment group
Group 1 (n=26): Patients will receive conventional treatment only of ulcerative colitis for 3 months.
Patients will receive previous conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months