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

NCT06340724 | Completed Phase 3

• 1 other identifier: KY20240123-08
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Eradication of H. pylori is assessed by a 13C-urea breath test (13C-UBT) performed 4 weeks after completion of eradication therapy (at week 6). A negative 13C-UBT result indicates successful eradication.

  At 4 weeks post-treatment (week 6)

Secondary Outcomes (4)

• Dyspeptic symptom score

  Baseline (week 0), immediately after 2-week treatment (week 2), and at follow-up (week 6)

• Incidence of adverse events

  During the 2-week treatment period (days 1-14)

• Medication adherence rate

  During the 2-week treatment period (days 1-14)

• Tongue coating microbiota composition

  Baseline (week 0), week 2, and week 6

Study Arms (2)

Vonoprazan-amoxicillin dual therapy

ACTIVE COMPARATOR

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

Drug: Vonoprazan; Drug: Amoxicillin

Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy

EXPERIMENTAL

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.

Drug: Vonoprazan; Drug: Amoxicillin; Drug: Banxiaxiexin decoction

Interventions

Banxiaxiexin decoction DRUG

100 ml liquid-medicine twice daily

Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy

Vonoprazan DRUG

20 mg tablet twice daily

Also known as: Vonoprazan fumarate

Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy; Vonoprazan-amoxicillin dual therapy

Amoxicillin DRUG

1 g tablet three times daily

Also known as: Amoxicillin Capsules

Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy; Vonoprazan-amoxicillin dual therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old
• Patients with H.pylori infection
• Diagnosed as functional dyspepsia
• Meet the diagnostic criteria of H. pylori cold-heat syndrome in traditional Chinese medicine.
• 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.
• Volunteer to participate in this experiment and sign the informed consent.

You may not qualify if:

• Allergy to research drugs (penicillin allergy, etc.)
• Patients with gastric and duodenal ulcer, pyloric obstruction, esophageal and gastric varices, gastrorrhagia, gastrointestinal mucosa with dysplasia, gastric malignant tumor and other gastrointestinal diseases.
• Patients with severe heart, brain, liver, kidney, hematopoietic system and connective tissue diseases
• Patients who have received H. pylori eradication treatment within six months.
• 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.
• Use adrenocortical hormone, non-steroidal anti-inflammatory drugs or anticoagulants.
• History of esophageal or gastric surgery
• Pregnant and lactating women

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospitai

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wanli Liu, Doctorate

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 1, 2024
• Study Start: February 15, 2024
• Primary Completion: November 30, 2024
• Study Completion: January 15, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

CN (1)