drugset / Trial / NCT04697186
Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims at evaluating efficacy and safety of berberine hydrochloride, amoxicillin and rabeprazole triple therapy versus bismuth-containing quadruple therapy(amoxicillin, clarithromycin, rabeprazole and bismuth) in the first eradication treatment of H. pylori. It is hypothesized that berberinehydrochloride, amoxicillin and rabeprazole 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
- 2021-01-07
- Primary completion
- 2021-12-20
- Completion
- 2021-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Berberine | Traditional medicine (herbal / TCM) | 300 mg | Oral |
| Comparator | Bismuth Potassium Citrate | Unknown | 220 mg | Oral |
| Comparator | Clarithromycin | Small molecule | 500 mg | Oral |
| Comparator | Amoxicillin | Other / unclassified | 1000 mg | Oral |
| Comparator | Rabeprazole | Small molecule | 10 mg | Oral |