Efficacy and Safety of Desloratadine as Adjuvant Therapy in Patients With Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in disease activity and severity
研究概览
简要总结
The purpose of this study is to investigate safety and therapeutic efficacy of antihistamine (desloratadine) on inflammation and disease activity when administered as adjuvant therapies with the traditional therapy 5-aminosalisylic acid (mesalamine) in patients with mild to moderate ulcerative colitis.
详细描述
Ulcerative colitis is a chronic inflammatory autoimmune disease affecting the colon. The World Health Organization has classified it as a relatively new treatment-resistant disease, and its prevalence has reportedly increased significantly in Egypt. A preclinical study was conducted to evaluate desloratadine as a potential therapeutic agent for ulcerative colitis, based on its known anti-inflammatory and antioxidant properties. The study concluded that desloratadine effectively alleviated experimental ulcerative colitis. This positive effect is attributed to its anti-inflammatory and antioxidant properties, which work by regulating mast cell activity and inhibiting histamine release.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female sex.
- •patients with age ranged from 18 to
- •patients with active mild and moderate ulcerative colitis according to American College of Gastroenterology (ACG) Clinical Guideline.
- •Patients treated with 5-aminosalisylic acid (mesalamine).
排除标准
- •Patients with severe UC
- •Significant liver or kidney function abnormalities
- •Pregnant or lactating females
- •Treatment with systemic or rectal steroids
- •Treatment with immunosuppressant or biological therapies
- •Known allergy to desloratadine or any ingredient in the formulation
- •Patients with other inflammatory diseases
- •Patients with history of colon cancer
- •Patients with complete or partial colectomy
研究组 & 干预措施
Group I (Control group)
which will receive mesalamine (standard treatment ) 1000 mg three times daily for 3 months and serve as the control group
干预措施: mesalamine (Drug)
Group II (Desloratadine group)
which will receive mesalamine (standard treatment )1000 mg three times daily plus desloratadine 5 mg once daily for 3 months
干预措施: Desloratadine (Drug)
结局指标
主要结局
Change in disease activity and severity
时间窗: over a 3 month follow -up period
Change in disease activity and severity through Partial Mayo Scoring Index (PMSI) and Truelove and Witt's classification
次要结局
- Change in serum biomarkers(Change from baseline in serum biomarker over 3 months)
研究者
Romisaa Raafat Abd Alnapy Mohamed
clinical pharmacy resident
Tanta University