High Dose Dual Therapy Vs. Standard Triple Therapy in the Eradication of Helicobacter Pylori: A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- The study design is designed as a superiority trial.
研究概览
简要总结
The study is a randomised control trial to compare the efficacy of high dose dual therapy and the standard triple therapy in eradication of Helicobacter pylori infection. It also aims to compare the compliance and adverse effects related to the drug regimens proposed for the study.
Patient undergoing upper gastrointestinal endoscopy in Department of Surgery shall be enrolled for the study if they the inclusion criteria. Convenient sampling shall be done and after obtaining the informed consent, patient shall receive either of the two drug regimens for a period of 14 days.
High dose dual therapy-
participants shall receive omeprazole 20 mg four times a day and amoxicillin 1 gram four times a day for 14 days
Standard triple therapy-
participants shall receive omeprazole 20 mg twice a day, amoxicillin 1 gram twice a day and clarithromycin 500 mg twice a day for 14 days.
Assessment of the efficacy shall be done 6 weeks later following the treatment by doing stool antigen test in a case of non ulcer disease and a repeat upper gastrointestinal endoscopy in a case of ulcer disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients more than 18 years of age who undergo esophagogastroduodenoscopy for the investigation of gastrointestinal symptoms in the Department of Surgery, JIPMER and are tested positive for Helocobacter pylori infection.
排除标准
- •Previous eradication therapy.
- •Patients who have used antibiotics within the previous 4 weeks.
- •Past history of developing allergy to any antibiotic used in the study.
- •Patients who have undergone gastrectomy.
- •Coexisting of severe concomitant medical illness.
- •Pregnancy or lactating women.
- •Patients diagnosed with any malignancies.
- •Patients with portal gastropathy.
结局指标
主要结局
The study design is designed as a superiority trial.
时间窗: 6 weeks
Aim is to compare the effectiveness of High Dose Dual Therapy in eradicating Helicobacter pylori infection.
时间窗: 6 weeks
Aim is to prove that the proposed regimen is superior to the Standard Triple therapy in eradiacting the Helicobacter pylori Infection, with a level of significance of 5 percent and margin of superiority of 2 percent.
时间窗: 6 weeks
次要结局
- To compare the compliance & adverse effects of High Dose Dual Therapy & Standard Triple Therapy.(2 weeks)
研究者
Geetankshi Gopal Ghabru
Jawaharlal Institute Of Postgraduate Medical Education and Research Dhanvantri Nagar Puducherry