Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication (NCT06340724) | Clinical Trial Compass
CompletedPhase 3
Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication
China104 participantsStarted 2024-02-15
Plain-language summary
Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical efficiency 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 18-65 years old
✓. Patients with H.pylori infection
✓. Diagnosed as functional dyspepsia
✓. Meet the diagnostic criteria of H. pylori cold-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 criteria
✕. 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.
What they're measuring
1
Helicobacter pylori eradication rate
Timeframe: At 4 weeks post-treatment (week 6)
Trial details
NCT IDNCT06340724
SponsorNanjing First Hospital, Nanjing Medical University