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

Nanjing Medical University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Amoxicillin; Drug: Vonoprazan; Drug: Banxiaxiexin decotion

Study type: Interventional

Funder types: Other

Identifiers

NCT06340724

KY20240123-08

Details and patient eligibility

About

Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical effiency 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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-65 years old
2. Patients with H.pylori infection
3. Diagnosed as functional dyspepsia
4. Meet the diagnostic criteria of H. pylori cold-heat syndrome in traditional Chinese medicine.
5. Patients who have not received H. pylori eradication treatment before, or who have failed eradication in the early stage but have not received eradication treatment within six months.
6. Volunteer to participate in this experiment and sign the informed consent.

Exclusion criteria

1. Allergy to research drugs (penicillin allergy, etc.)
2. Patients with gastric and duodenal ulcer, pyloric obstruction, esophageal and gastric varices, gastrorrhagia, gastrointestinal mucosa with dysplasia, gastric malignant tumor and other gastrointestinal diseases.
3. Patients with severe heart, brain, liver, kidney, hematopoietic system and connective tissue diseases
4. Patients who have received H. pylori eradication treatment within six months.
5. Antibiotics and bismuth were used 4 weeks before the start of study treatment, and histamine H2 receptor antagonist or PPI was used 2 weeks before the start of study treatment.
6. Use adrenocortical hormone, non-steroidal anti-inflammatory drugs or anticoagulants.
7. History of esophageal or gastric surgery
8. Pregnant and lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Vonoprazan-amoxicillin dual therapy

Active Comparator group

Description:

Participants received Vonoprazan 20 mg tablet orally twice daily and Amoxicillin 1 g tablet orally three times daily for 2 weeks.

Treatment:

Drug: Vonoprazan

Drug: Amoxicillin

Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy

Experimental group

Description:

Participants received Vonoprazan 20 mg tablet orally twice daily,Amoxicillin 1 g tablet and Banxiaxiexin decoction 100 ml liquid-medicine orally three times daily for 2 weeks.

Treatment:

Drug: Vonoprazan

Drug: Banxiaxiexin decotion

Drug: Amoxicillin