Role of Roflumilast in Ulcerative Colitis

Status Not yet recruiting

Clinical Trial Summary

This study aims to investigate possible efficacy and safety of Roflumilast in adult patients with ulcerative colitis disease .

Clinical Trial Description

- Study design and study population This study will be randomized, controlled, parallel study. - It will be conducted on 52 patient having with mild to moderate degree ulcerative colitis disease divided into two groups 1. Group 1 (n=26): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 3 months. 2. Group 2 (n=26): Patients will receive previous conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months - Patient will be selected from Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital. - A written informed consent will be obtained from all patients - This study will be approved by the Research Ethics Committee of Tanta University. - Any unexpected risks appeared during the course of research will be reported to the participants and ethical committee on time and documented through an adverse effects reporting form . - Randomization will be carried out based on days of hospital admission ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05684484
Study type	Interventional
Source	Tanta University
Contact	ahmed m. youness, master degree
Phone	0020114718892
Email	ahmedyounes881@gmail.com
Status	Not yet recruiting
Phase	Phase 4
Start date	February 1, 2023
Completion date	November 2024

View Details

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