14-day Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in the Treatment of Helicobacter Pylori Infection Complicated With Functional Dyspepsia:A Single-Center,Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical efficiency and safety of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori infection complicated with functional dyspepsia,through a randomized controlled trail.
详细描述
Helicobacter pylori（H.pylori）is a gastric pathogen, related to various gastrointestinal disorders. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Vonoprazan and high-dose amoxicillin dual therapy is a potential H.pylori eradication regimen. It provides a satisfactory eradication rate of 90%. Nevertheless,it has certain limitations, including a series of problems such as low eradication rate and more side effects of eradication in recurrent patients. The main side effects of the dual therapy for eradication are related symptoms of gastric motility deficiency and indigestion, such as bloating, abdominal pain, belching, acid reflux, etc. Combining traditional Chinese medicine may be one of the effective ways to solve the above problems.This study aims to compare the efficacy of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy,with that of vonoprazan and high-dose amoxicillin dual therapy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old
- •Patients with H.pylori infection
- •Diagnosed as functional dyspepsia
- •Meet the diagnostic criteria of H. pylori cold-heat syndrome in traditional Chinese medicine.
- •Patients who have not received H. pylori eradication treatment before, or who have failed eradication in the early stage but have not received eradication treatment within six months.
- •Volunteer to participate in this experiment and sign the informed consent.
排除标准
- •Allergy to research drugs (penicillin allergy, etc.)
- •Patients with gastric and duodenal ulcer, pyloric obstruction, esophageal and gastric varices, gastrorrhagia, gastrointestinal mucosa with dysplasia, gastric malignant tumor and other gastrointestinal diseases.
- •Patients with severe heart, brain, liver, kidney, hematopoietic system and connective tissue diseases
- •Patients who have received H. pylori eradication treatment within six months.
- •Antibiotics and bismuth were used 4 weeks before the start of study treatment, and histamine H2 receptor antagonist or PPI was used 2 weeks before the start of study treatment.
- •Use adrenocortical hormone, non-steroidal anti-inflammatory drugs or anticoagulants.
- •History of esophageal or gastric surgery
- •Pregnant and lactating women
研究组 & 干预措施
Vonoprazan-amoxicillin dual therapy
Participants received Vonoprazan 20 mg tablet orally twice daily and Amoxicillin 1 g tablet orally three times daily for 2 weeks.
干预措施: Vonoprazan (Drug)
Vonoprazan-amoxicillin dual therapy
Participants received Vonoprazan 20 mg tablet orally twice daily and Amoxicillin 1 g tablet orally three times daily for 2 weeks.
干预措施: Amoxicillin (Drug)
Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy
Participants received Vonoprazan 20 mg tablet orally twice daily,Amoxicillin 1 g tablet and Banxiaxiexin decoction 100 ml liquid-medicine orally three times daily for 2 weeks.
干预措施: Vonoprazan (Drug)
Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy
Participants received Vonoprazan 20 mg tablet orally twice daily,Amoxicillin 1 g tablet and Banxiaxiexin decoction 100 ml liquid-medicine orally three times daily for 2 weeks.
干预措施: Amoxicillin (Drug)
Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy
Participants received Vonoprazan 20 mg tablet orally twice daily,Amoxicillin 1 g tablet and Banxiaxiexin decoction 100 ml liquid-medicine orally three times daily for 2 weeks.
干预措施: Banxiaxiexin decoction (Drug)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: At 4 weeks post-treatment (week 6)
Eradication of H. pylori is assessed by a 13C-urea breath test (13C-UBT) performed 4 weeks after completion of eradication therapy (at week 6). A negative 13C-UBT result indicates successful eradication.
次要结局
- Dyspeptic symptom score(Baseline (week 0), immediately after 2-week treatment (week 2), and at follow-up (week 6))
- Incidence of adverse events(During the 2-week treatment period (days 1-14))
- Medication adherence rate(During the 2-week treatment period (days 1-14))
- Tongue coating microbiota composition(Baseline (week 0), week 2, and week 6)