ISRCTN12785009进行中（未招募）未知
Randomised multicentric controlled clinical trial to compare efficacy of Jinghuaweikang capsule combined quadruple therapy versus quadruple therapy on the refractory infection of Helicobacter pylori
China Health Promotion Foundation0 个研究点目标入组 510 人开始时间: 2018年5月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 510
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 to 65 without gender limitation.
- •2. Meet the refractory Helicobacter pylori infection:
- •2.1. Referred after three or more than three standard therapy (according to consensus for 10-14 days, at least two times of standard quadruple therapy, at least one time for 14 days) failures in three years.
- •2.2. Received upper endoscopy and suitable for eradication of Helicobacter pylori.
- •3. Diagnosed with Helicobacter pylori infection by rapid urease test or 13C-urea breath test results.
- •4. Proven endoscopic gastritis (including atrophic gastritis and non-atrophic gastritis) or ulcers.
- •5. Participants without prior penicillin treatment need to demonstrate negative reaction to penicillin skin test.
- •6. No dyspepsia syndromes of epigastric discomfort, epigastric pain, acid regurgitation, heartburn, and so on, but meet indication of Helicobacter pylori eradication.
- •7. Accept the medications treatment voluntarily and signed informed consent.
排除标准
- •1. History of stomach operation: partial gastrectomy, stomach plasty, vagotomy (but patients who had simple repair of gastroduodenal ulcer perforation or hemostatic suture of gastroduodenal ulcer were accepted)
- •2. Pregnancy or lactation, or childbearing age women without reliable contraception (e.g.,oophorectomy, hysterectomy, at least 6 months of tubal ligation, oral contraceptives, barrier method of contraception)
- •3. Cannot avoid alcohol during the experiment
- •4 Patients who concomitant with liver disease, kidney disease, cardiovascular disease, brain disease, pulmonary disease, endocrine system diseases, hematopoietic system disease, and other serious primary diseases which is not effectively controlled
- •5. Severe hepatic and renal insufficiency( transaminase is more than 1.5 times of the normal limit, or serum creatinine more than the upper limit of normal )or liver disease, anemia (hemoglobin < 90 g/L)
- •6. Allergic to furazolidone, penicillin, rabeprazole or ingredients of JinghuaWeikang Capsule
- •7. Used antibiotics, bismuth agent (>three timesper week) or clinical trial other drugs within 30 days
- •8 . Taking anticoagulant therapy or non-steroidal anti-inflammatory drugs (NSAIDs)
- •9. Swallowing difficulties
- •10. Used anti-ulcer drugs, including H2-receptor blocking agent, sucralfate, misoprostol or proton pump inhibitor (PPI) within two weeks
- •11. Zollinger-Ellison syndrome
- •12. Malignant tumor
- •13. Included in another clinical trial within 3 months
- •14. Inappropriate according to the investigator
研究者
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