Status:
NOT_YET_RECRUITING
Zuojin Wan Combined with Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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 thera...
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. Vono...
Eligibility Criteria
Inclusion
- Age 18-65 years old
- Patients with H.pylori infection
- Diagnosed as functional dyspepsia
- Meet the diagnostic criteria of H. pylori liver-atomach stagnation heat syndrome in traditional Chinese medicine.
- 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.
- Volunteer to participate in this experiment and sign the informed consent.
Exclusion
- Allergy to research drugs (penicillin allergy, etc.)
- Patients with gastric and duodenal ulcer, pyloric obstruction, esophageal and gastric varices, gastrorrhagia, gastrointestinal mucosa with dysplasia, gastric malignant tumor and other gastrointestinal diseases.
- Patients with severe heart, brain, liver, kidney, hematopoietic system and connective tissue diseases
- Patients who have received H. pylori eradication treatment within six months.
- 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.
- Use adrenocortical hormone, non-steroidal anti-inflammatory drugs or anticoagulants.
- History of esophageal or gastric surgery
- Pregnant and lactating women
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT06901375
Start Date
May 1 2025
End Date
August 1 2025
Last Update
March 28 2025
Active Locations (1)
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1
Nanjing First Hospitai
Nanjing, Jiangsu, China, 210006