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

Early Phase 1

Not yet recruiting

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Banxiaxiexin decotion

• Registration Number: NCT06340724
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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.

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.

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-04-01
• Last Update Posted: 2024-04-01
• Primary Completion: 2024-10
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy	Banxiaxiexin decotion	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.
Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy	Vonoprazan	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.
Vonoprazan-amoxicillin dual therapy	Vonoprazan	Participants received Vonoprazan 20 mg tablet orally twice daily and Amoxicillin 1 g tablet orally three times daily for 2 weeks.
Vonoprazan-amoxicillin dual therapy	Amoxicillin	Participants received Vonoprazan 20 mg tablet orally twice daily and Amoxicillin 1 g tablet orally three times daily for 2 weeks.
Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy	Amoxicillin	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in functional dyspepsia symptoms at 6 weeks	Baseline and Week 6	Functional dyspepsia symptoms on days 7,14,28 and 42 were assessed using Likert scale
Change in Traditional Chinese Medicine syndromes from Baseline to 6 weeks	Baseline and Week 6	Traditional Chinese Medicine syndromes on days 7,14,28 and 42 were assessed using TCM syndrome integral scale

Secondary Outcome Measures

Name	Time	Method
Adverse reactions that occur after taking medication	day 1 and day 14	The patients were followed up by telephone on the days 7 and 14
Patients' drug compliance	day 1 and day 14	Patients' drug compliance was assessed using medication possession ratio

Trial Locations

Locations (1)

Nanjing First Hospitai; 🇨🇳 Nanjing, Jiangsu, China