drugset / Trial / NCT06514274
Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study was to evaluate the efficacy and safety of the triple therapy of berberine hydrochloride, vonorasan and amoxicillin for the primary eradication of Helicobacter pylori.It is hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Timeline
- Start
- 2024-09-20
- Primary completion
- 2025-04-30
- Completion
- 2025-06-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Berberine | Traditional medicine (herbal / TCM) | 500 mg | Oral |
| Comparator | Bismuth Potassium Citrate | Unknown | 220 mg | Oral |
| Comparator | Clarithromycin | Small molecule | 500 mg | Oral |
| Comparator | Esomeprazole | Small molecule | 10 mg | Oral |
| Subject | Vonoprazan | Other / unclassified | 20 mg | Oral |
| Background | Amoxicillin | Other / unclassified | 1000 mg | Oral |