Traditional Chinese Medicine Combined With Standard Triple Region for Eradication of Helicobacter Pylori: a Prospective, Double-blinded, Randomized Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 576
- 主要终点
- H. pylori eradication rate
研究概览
简要总结
To evaluate the efficacy and safety of Traditional Chinese Medicine (TCM) decoction and powder combined with standard triple therapy on improving eradication rate of Helicobacter Pylori (H. pylori).A multi-center randomized control clinical trial design was adopted in the trial.
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
- Double (Participant, Investigator)
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
- •those who met chronic gastritis (chronic superficial gastritis and chronic atrophic gastritis) diagnostic criteria;
- •aged between 18-65 years old;
- •positive H. pylori infection confirmed by two or more methods of different
- •principles (stop using PPI, H2RA, bismuth, and antibiotics since two weeks before examination);
- •patients were informed consent and willing to accept corresponding treatments.
- •Exclusion criteria:
- •Patients having chronic atrophic gastritis with severe dysplasia, upper gastrointestinal bleeding, peptic ulcers, and gastrointestinal tumors;
- •digestive organic disease (such as chronic pancreatitis, cirrhosis, etc.), or systemic diseases affecting intestinal motility (such as hyperthyroidism, diabetes mellitus, chronic renal insufficiency, mental, and neurological diseases, etc.);
- •those who were accompanied by serious heart, liver and other major organs lesions, blood diseases, and cancer (ALT, AST two times higher than normal value);
- •those who had taken medicines that might affect H. pylori detection results within two weeks (antacids, H2RA, PPIs, bismuth and antibiotics, etc.);
- •pregnant and lactating women; patients with history of systematic and neuropsychiatric disorders; those who had history of any drug allergy; and those who were participating in other clinical trials.
排除标准
- 未提供
研究组 & 干预措施
standard triple region
The patients in this group were given 10-day standard triple therapy.
干预措施: standard triple region (Drug)
standard triple region +2-week TCM
The patients in this group were given 10 days of standard triple therapy + 2-week Xiang-sha-liu-jun decoction.
干预措施: standard triple region (Drug)
standard triple region +2-week TCM
The patients in this group were given 10 days of standard triple therapy + 2-week Xiang-sha-liu-jun decoction.
干预措施: 2-week Xiang-sha-liu-jun decoction (Drug)
standard triple region +4-week TCM
The patients in this group were given 10days of standard triple therapy + 4-week Xiang-sha-liu-jun decoction.
干预措施: standard triple region (Drug)
standard triple region +4-week TCM
The patients in this group were given 10days of standard triple therapy + 4-week Xiang-sha-liu-jun decoction.
干预措施: 4-week Xiang-sha-liu-jun decoction (Drug)
结局指标
主要结局
H. pylori eradication rate
时间窗: 13C or 14C urea breath test was performed at four weeks after western medicine termination.
次要结局
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment(at baseline, and every week up to four weeks.)