Zuojin Wan Combined with Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication
Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Mar 23, 2025
Trial Information
Current as of April 30, 2025
Not yet recruiting
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
About Nanjing First Hospital, Nanjing Medical University
Nanjing First Hospital, affiliated with Nanjing Medical University, is a leading medical institution dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care and cutting-edge medical practices, the hospital serves as a key player in the development of new therapies and treatment protocols. Its collaborative environment fosters interdisciplinary research, enabling the integration of scientific inquiry with clinical application. Nanjing First Hospital is committed to improving health outcomes and contributing to the global medical community through rigorous trial design and execution, ensuring the highest standards of ethical practice and patient safety.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nanjing, Jiangsu, China
Patients applied
Trial Officials
Wanli Liu, Doctorate
Study Chair
Nanjing First Hospital, Nanjing Medical University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported