NCT06340724

Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication

14-day Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in the Treatment of Helicobacter Pylori Infection Complicated With Functional Dyspepsia:A Single-Center,Randomized Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical efficiency and safety of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori infection complicated with functional dyspepsia,through a randomized controlled trail.

Detailed description

Helicobacter pylori（H.pylori）is a gastric pathogen, related to various gastrointestinal disorders. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Vonoprazan and high-dose amoxicillin dual therapy is a potential H.pylori eradication regimen. It provides a satisfactory eradication rate of 90%. Nevertheless,it has certain limitations, including a series of problems such as low eradication rate and more side effects of eradication in recurrent patients. The main side effects of the dual therapy for eradication are related symptoms of gastric motility deficiency and indigestion, such as bloating, abdominal pain, belching, acid reflux, etc. Combining traditional Chinese medicine may be one of the effective ways to solve the above problems.This study aims to compare the efficacy of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy,with that of vonoprazan and high-dose amoxicillin dual therapy.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Vonoprazan	20 mg tablet twice daily
DRUG	Amoxicillin	1 g tablet three times daily
DRUG	Banxiaxiexin decoction	100 ml liquid-medicine twice daily

Timeline

• Start date: 2024-02-15
• Primary completion: 2024-11-30
• Completion: 2025-01-15
• First posted: 2024-04-01
• Last updated: 2026-02-18

Locations

1 site across 1 country: China