drugset / Trial / NCT03609892
Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims at evaluating efficacy and safety of berberine- amoxicillin containing quadruple therapy(berberine, amoxicillin, esomeprazole and bismuth) versus tetracycline-furazolidone quadruple therapy (tetracycline, furazolidone, esomeprazole and bismuth) in H. pylori rescue therapy. It is hypothesized that berberine-amoxicillin containing quadruple therapy is non-inferior to tetracycline-furazolidone quadruple therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. 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
- 2018-08-01
- Primary completion
- 2019-08-20
- Completion
- 2019-08-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 1000 mg | — |
| Subject | Berberine | Traditional medicine (herbal / TCM) | 300 mg | — |
| Comparator | Furazolidone | Small molecule | 100 mg | — |
| Comparator | Tetracycline | Unknown | 500 mg | — |
| Comparator | Bismuth Potassium Citrate | Unknown | 200 mg | — |
| Comparator | Esomeprazole | Small molecule | 20 mg | — |