Helicobacter Pylori Infection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGVonoprazan
20 mg tablet twice daily
DRUGAmoxicillin
1 g tablet three times daily
DRUGZuojin Wan
3 g tablet twice daily
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 years old 2. Patients with H.pylori infection 3. Diagnosed as functional dyspepsia 4. Meet the diagnostic criteria of H. pylori liver-atomach stagnation heat syndrome in traditional Chinese medicine. 5. 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. 6. Volunteer to participate in this experiment and sign the informed consent.
Exclusion criteria
1. Allergy to research drugs (penicillin allergy, etc.) 2. Patients with gastric and duodenal ulcer, pyloric obstruction, esophageal and gastric varices, gastrorrhagia, gastrointestinal mucosa with dysplasia, gastric malignant tumor and other gastrointestinal diseases. 3. Patients with severe heart, brain, liver, kidney, hematopoietic system and connective tissue diseases 4. Patients who have received H. pylori eradication treatment within six months. 5. 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. 6. Use adrenocortical hormone, non-steroidal anti-inflammatory drugs or anticoagulants. 7. History of esophageal or gastric surgery 8. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in functional dyspepsia symptoms at 6 weeks | Baseline and Week 6 | 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. |
| Change in Traditional Chinese Medicine syndromes from Baseline to 6 weeks | Baseline and Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events during the treatment | day 1 and day 14 | The occurrence of adverse events during treatment will be recorded by telephone follow-up. |
| Patients' drug compliance | day 1 and day 14 | Patients' drug compliance was assessed using medication possession ratio |
Countries
China
Contacts
Primary ContactWenjuan Wei, Doctorate
Backup ContactWanli Liu, Doctorate
Outcome results
None listed