Zuojin Wan Combined with Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Mar 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for Helicobacter pylori infection, which can cause stomach issues like chronic gastritis. Researchers want to see how well a traditional Chinese medicine called Zuojin Wan works when combined with two other medications, vonoprazan and high-dose amoxicillin. The trial will compare this combination to a standard treatment using just vonoprazan and high-dose amoxicillin to determine which is more effective and safe for patients.

To be eligible for this trial, participants should be between 18 and 65 years old and have been diagnosed with an H. pylori infection and functional dyspepsia, a term that refers to stomach discomfort. They should not have received treatment for H. pylori before, or if they have, it should have been unsuccessful at least six months ago. Participants will be asked to volunteer for the study and sign consent forms. Importantly, individuals with certain health conditions, allergies to the study medications, or those who are pregnant or breastfeeding cannot participate. If you join the trial, you can expect close monitoring and support from the research team throughout the treatment process.

Gender

ALL

Eligibility criteria

• 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