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Completed

NCT Number: NCT06340724

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nanjing First Hospitai

Nanjing, Jiangsu, 210006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Vonoprazan

Drug

20 mg tablet twice daily

Other names: Vonoprazan fumarate

Amoxicillin

Drug

1 g tablet three times daily

Other names: Amoxicillin Capsules

Banxiaxiexin decoction

Drug

100 ml liquid-medicine twice daily

Primary outcomes

  1. Helicobacter pylori eradication rate

    Time frame: At 4 weeks post-treatment (week 6)

    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.

Secondary outcomes

  1. Dyspeptic symptom score

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

    Dyspeptic symptoms (epigastric pain, epigastric burning, postprandial fullness, early satiation) are assessed using a 4-point Likert scale for both frequency and severity. Frequency is graded as 0 (none), 1 (1-2 days/week for pain/burning; 3 days/week for fullness/satiation), 2 (3-4 days/week for pain/burning; 4-5 days/week for fullness/satiation), or 3 (≥5 days/week for pain/burning; 6-7 days/week for fullness/satiation). Severity is graded as 0 (none), 1 (mild, does not affect daily activities), 2 (moderate, can be tolerated but partially affects daily activities), or 3 (severe, difficult to tolerate and significantly affects daily activities). The total symptom score is calculated as the sum of (frequency score × severity score) for each symptom, with a possible range from 0 to 36. Higher scores indicate worse dyspeptic symptoms.

  2. Incidence of adverse events

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

    Adverse events occurring during the treatment period are recorded via telephone follow-up. The incidence and type of adverse events are documented.

  3. Medication adherence rate

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

    Medication adherence is evaluated using the medication possession ratio (MPR). MPR is calculated as (actual number of doses taken / expected number of doses) × 100%. Good adherence is defined as MPR ≥80%; poor adherence as MPR <80%.

  4. Tongue coating microbiota composition

    Time frame: Baseline (week 0), week 2, and week 6

    Tongue coating samples are collected at baseline (week 0), after 2-week treatment (week 2), and at follow-up (week 6). Samples are obtained by swabbing a 2 cm × 2 cm area on the dorsal tongue surface with a sterile cotton swab after rinsing with saline. Samples are stored at -80 °C for subsequent 16S rRNA sequencing to analyze changes in microbiota composition and diversity.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 1, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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