Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection Treatment in the Elderly Patient, a Multi-center, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
This is an open-label, randomized controlled trial. The aim of the study is to evaluate the efficacy and safety of the Qingre Huashi Granules combined the modified dual therapy (or called high dose dual therapy) for Helicobacter pylori infection specifically in geriatric patients, compared with the bismuth containing quadruple therapy. A total of 160 eligible patients will be enrolled in 4 hospitals. The eradication rate, symptoms, and the adverse events will be recorded and analyzed.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current Helicobacter pylori infection.
- •Age ≥ 60 years.
- •Diagnosed with syndrome of dampness-heat by Traditional Chinese Medicine.
- •Signed the informed consent document.
排除标准
- •History of Helicobacter pylori treatment.
- •History of gastric surgery.
- •Allergic to any medications involved in the intervention.
- •Sever complications, such as lung dysfunction, uncontrolled hypertension, diabetes, cardiovascular disease, renal dysfunction (eGFR<60ml/min'1.73m2) , malignant tumor，mental disorder.
- •Taking medications that may be conflict to the intervention drugs.
- •Failing to express symptoms, unwilling to cooperate.
- •Taking any antibiotics within a month.
研究组 & 干预措施
QHD group
Qingre Huashi Granules 1 package twice daily, Rabeprazole 20mg triple daily, Amoxycillin 1g triple daily. The duration is 14 days.
干预措施: Qingre Huashi Granules combined the modified dual therapy (Drug)
Control group
Rabeprazole 20mg twice daily, bismuth potassium citrate 220mg twice daily, Amoxycillin 1g twice daily, clarithromycin 500mg twice daily. The duration is 14 days.
干预措施: Bismuth containing quadruple therapy (Drug)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: The 4th week after the treatment.
At the 4th week after the treatment, the 13-carbon urease test was conducted to evaluate the eradication condition. The value of "delta over baseline" \<4 was considered to be successful eradication.
次要结局
- 7-point Global Overall Symptom Scale(Baseline, the second and sixth week after the treatment, respectively.)
- Efficacy Scale of the Dampness-heat syndrome(Baseline, the second and sixth week after the treatment, respectively.)
- Adverse events rate(During the follow-up, up to 6 weeks.)