Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical efficiency and safety of Zuojin Wan combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori associated chronic gastritis,through a randomized controlled trail.
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 Zuojin Wan combined with vonoprazan and high-dose amoxicillin dual therapy,with that of vonoprazan and high-dose amoxicillin dual therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
20 mg tablet twice daily
1 g tablet three times daily
3 g tablet twice daily
Nanjing First Hospitai
Nanjing, Jiangsu, China
Change from Baseline in functional dyspepsia symptoms at 6 weeks
Dyspepsia symptoms on days 7,14 and 42 were assessed using Likert scale； Scale tittle:Symptom frequency and severity criteria table； The minimum value：8；the maximum value：40； Higher scores mean a worse outcome.
Time frame: Baseline and Week 6
Change in Traditional Chinese Medicine syndromes from Baseline to 6 weeks
Traditional Chinese Medicine syndromes on days 7,14 and 42 were assessed using Traditional Chinese Medicine syndrome integral scale.Scale tittle:Traditional Chinese Medicine syndrome integral scale; The minimum value：0；the maximum value：30； Higher scores mean a worse outcome.
Time frame: Baseline and Week 6
Adverse events during the treatment
The occurrence of adverse events during treatment will be recorded by telephone follow-up.
Time frame: day 1 and day 14
Patients' drug compliance
Patients' drug compliance was assessed using medication possession ratio
Time frame: day 1 and day 14
Wanli Liu, Doctorate
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