drugset / Trial / NCT02633930
Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims at evaluating efficacy and safety of berberine-containing quadruple therapy(berberine, lansoprazole, bismuth and amoxicillin) versus clarithromycin-containing quadruple therapy (clarithromycin,lansoprazole, bismuth and amoxicillin) in H. pylori eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior to clarithromycin-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.
Timeline
- Start
- 2015-12
- Primary completion
- 2016-06
- Completion
- 2016-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Berberine | Traditional medicine (herbal / TCM) | 300 mg | Oral |
| Comparator | Clarithromycin | Small molecule | 500 mg | Oral |
| Background | Amoxicillin | Other / unclassified | 1000 mg | Oral |
| Background | Bismuth Potassium Citrate | Unknown | 220 mg | Oral |
| Background | Lansoprazole | Other / unclassified | 30 mg | Oral |