Helicobacter Pylori InfectionPhase 3NCT06340724
Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication
A Phase 3 study testing Vonoprazan, Amoxicillin and Banxiaxiexin decoction in people with Helicobacter Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vonoprazan, Amoxicillin and Banxiaxiexin decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2024to 15 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vonoprazan, Amoxicillin, Banxiaxiexin decoction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Also called Vonoprazan fumarate
20 mg tablet twice daily
AmoxicillinDrug
Also called Amoxicillin Capsules
1 g tablet three times daily
Banxiaxiexin decoctionDrug
100 ml liquid-medicine twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Banxiaxiexin decoction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 4 weeks post-treatment (week 6)
Secondary outcomes (4)
Dyspeptic symptom score
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.
Measured: Baseline (week 0), immediately after 2-week treatment (week 2), and at follow-up (week 6)
Incidence of adverse events
Adverse events occurring during the treatment period are recorded via telephone follow-up. The incidence and type of adverse events are documented.
Measured: During the 2-week treatment period (days 1-14)
Medication adherence rate
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%.
Measured: During the 2-week treatment period (days 1-14)
Tongue coating microbiota composition
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.
Measured: Baseline (week 0), week 2, and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start15 Feb 2024
- Primary completion30 Nov 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wanli Liu, Doctorate, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340724
- Sponsor's protocol ID
- KY20240123-08
- Status last verified
- Feb 2026
- First submitted
- 26 Mar 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06340724
- Acronym / sponsor ID
- KY20240123-08
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan-amoxicillin dual therapy | Active comparator | Drug: Vonoprazan, Drug: AmoxicillinParticipants 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 | Experimental | Drug: Vonoprazan, Drug: Amoxicillin, Drug: Banxiaxiexin decoctionParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VonoprazanAlso: Vonoprazan fumarate20 mg tablet twice daily | Drug | Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy, Vonoprazan-amoxicillin dual therapy |
| AmoxicillinAlso: Amoxicillin Capsules1 g tablet three times daily | Drug | Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy, Vonoprazan-amoxicillin dual therapy |
| Banxiaxiexin decoction100 ml liquid-medicine twice daily | Drug | Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy |
Primary outcome
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.
4 secondary outcomes
Dyspeptic symptom score
Time frame: Baseline (week 0), immediately after 2-week treatment (week 2), and at follow-up (week 6)
Incidence of adverse events
Time frame: During the 2-week treatment period (days 1-14)
Medication adherence rate
Time frame: During the 2-week treatment period (days 1-14)
Tongue coating microbiota composition
Time frame: Baseline (week 0), week 2, and week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wanli Liu, Doctorate study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vonoprazan, Amoxicillin and Banxiaxiexin decoction in people with Helicobacter Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication rate (time frame: At 4 weeks post-treatment (week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.