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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06340724
• Other study ID #: KY20240123-08
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: March 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Wenjuan Wei, Doctorate
• Phone: +8618851009006
• Email: wjwei.hf[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• Vonoprazan
20 mg tablet twice daily
• Amoxicillin
1 g tablet three times daily
• Banxiaxiexin decotion
100 ml liquid-medicine twice daily

Locations

Country	Name	City	State
China	Nanjing First Hospitai	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in functional dyspepsia symptoms at 6 weeks	Functional dyspepsia symptoms on days 7,14,28 and 42 were assessed using Likert scale	Baseline and Week 6
Primary	Change in Traditional Chinese Medicine syndromes from Baseline to 6 weeks	Traditional Chinese Medicine syndromes on days 7,14,28 and 42 were assessed using TCM syndrome integral scale	Baseline and Week 6
Secondary	Adverse reactions that occur after taking medication	The patients were followed up by telephone on the days 7 and 14	day 1 and day 14
Secondary	Patients' drug compliance	Patients' drug compliance was assessed using medication possession ratio	day 1 and day 14