A Non blinded Randomized Controlled Trial to assess the efficacy of Helicobacter pylori eradication in patients with chronic urticaria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Helicobacter pylori eradication in the management of chronic urticaria
研究概览
简要总结
All patients between 18 to 70 years with diagnosis of chronic urticaria coming to Dermatology OPD, Sir Sunderlal Hospital, BHU will be included in the study. Occurence of H. pylori infection in these patients will be assessed by estimating antigen for H. pylori in stool samples by ELISA based test. All H. pylori antigen positive patients will be randomized in 2 arms in 1:1 ratio with computer generated random number.
Group A will be given H. pylori eradication kit ( tinidazole 500 mg BD + clarithromycin 250 mg BD + lansoprazole 30 mg BD) for 14 days with standard of care treatment for urticaria for 3 months.
Group B will be given standard of care treatment for urticaria for 3 months.
All antigen negative patients will be excluded from the study.
All patients will be followed up for 3 months and response evaluation will be done by Urticaria Activity Score over 7 days (UAS7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All clinically diagnosed cases of chronic urticaria with a positive result in the Helicobacter pylori stool antigen test.
排除标准
- •Patients taking proton pump inhibitors/ H2 blockers/ antibiotics/ oral steroids in last 2 weeks.
结局指标
主要结局
To evaluate the effect of Helicobacter pylori eradication in the management of chronic urticaria
时间窗: Follow up at 3 months and 6 months
次要结局
- Successful eradication of Helicobacter pylori(After completion of eradication therapy for 14 days)