Phytomedicine-based and Quadruple Therapies in Helicobacter Pylori Infection. A Comparative Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- H. pylori eradication rate was the primary endpoint, which was considered to be achieved on the basis of a negative urea breath and stool antigen test four weeks after the end of treatment
研究概览
简要总结
Helicobacter pylori is strongly associated to the development of gastrointestinal disorders. Emerging antibiotic resistance and poor patient compliance of modern therapies has resulted in significant eradication failure. Clinical trial was conducted to see the efficacy of current quadruple and phytomedicine-based therapies for the eradication of H. pylori infection and relief in its associated symptoms in Pakistan.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients suffering from H. pylori infection
- •Patients having no previous record of treatment against H. pylori infection
- •Patients living in Karachi, Rawalpindi and Bahawalpur
- •Patients having no pathological complications on routine examination
- •All socioeconomic classes were included in the study
- •Male and female patients between 15 to 45 years of age
排除标准
- •there was peptic ulceration, gastrointestinal bleeding or gastric carcinoma
- •if history of use of antibiotics, proton-pump inhibitors or bismuth compound in the last one month before test
- •any patient found to be allergic or intolerant to therapeutic regimens
- •they failed to report for follow-up
研究组 & 干预措施
Pylorex plus
Pylorex plus consisting of medicinal plants.
干预措施: Quadruple Allopathic therapy (Drug)
Pylorex plus
Pylorex plus consisting of medicinal plants.
干预措施: Pylorex plus (Drug)
Quadruple therapy
Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate)
干预措施: Quadruple Allopathic therapy (Drug)
Quadruple therapy
Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate)
干预措施: Pylorex plus (Drug)
结局指标
主要结局
H. pylori eradication rate was the primary endpoint, which was considered to be achieved on the basis of a negative urea breath and stool antigen test four weeks after the end of treatment
时间窗: 1 month
次要结局
- The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores(1 month)
研究者
Hafiz Muhammad Asif
Doctor
Shifa Ul Mulk Memorial Hospital