14-day Banxiaxiexin Decocton Combined With Vonoprazan-Amoxicillin Dual Therapy in the Treatment of Helicobacter Pylori Infection Complicated With Functional Dyspepsia:A Monocenter,Randomized Controlled Study

KY20240123-08

Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical effiency 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.

2024-03-01

2024-10-01

2025-03-01

Not yet recruiting

Early phase I

100

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 cold-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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-04-01