drugset / Trial / NCT05364619
Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection
Unknown
160 enrolled
Peking University First Hospital
Beijing Changping Integrative Medicine Hospital · collabBeijing Geriatric Hospital · collabPeking University International Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, randomized controlled trial. The aim of the study is to evaluate the efficacy and safety of the Qingre Huashi Granules combined the modified dual therapy (or called high dose dual therapy) for Helicobacter pylori infection specifically in geriatric patients, compared with the bismuth containing quadruple therapy. A total of 160 eligible patients will be enrolled in 4 hospitals. The eradication rate, symptoms, and the adverse events will be recorded and analyzed.
Timeline
- Start
- 2022-08-05
- Primary completion
- 2024-12-01
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 1 g | — |
| Comparator | Bismuth Potassium Citrate | Unknown | 220 mg | — |
| Comparator | Clarithromycin | Small molecule | 500 mg | — |
| Subject | Qingre Huashi Granules | Unknown | 1 unknown | — |
| Subject | Rabeprazole | Small molecule | 20 mg | — |