Helicobacter Pylori InfectionEarly Phase 1NCT06901375
Zuojin Wan Combined with Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication
A Early Phase 1 study testing Vonoprazan, Amoxicillin and Zuojin Wan 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 Zuojin Wan combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori associated chronic gastritis,through a randomized controlled trail. 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 Zuojin Wan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- May 2025to Aug 2025
- Phase
- Early Phase 1
- 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 liver-atomach stagnation 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.
Wanli Liu, Doctorate contact
About this study
Official title: 14-day Zuojin Wan Combined with Vonoprazan-Amoxicillin Dual Therapy in the Treatment of Helicobacter Pylori Associated Chronic Gastritis: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 Zuojin Wan combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori associated chronic gastritis,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 Zuojin Wan 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, Zuojin Wan
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
Zuojin WanDrug
Also called Zuojin Pill
3 g tablet 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 |
| Zuojin Wan ombined with vonoprazan-amoxicillin dual therapy | Experimental | Participants received Vonoprazan 20 mg tablet,Zuojin Wan 3 g tablet orally twice daily and Amoxicillin 1 g tablet orally three times daily for 10 days. Receives: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Zuojin Wan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in functional dyspepsia symptoms at 6 weeks
Dyspepsia symptoms on days 7,14 and 42 were assessed using Likert scale； Scale tittle:Symptom frequency and severity criteria table； The minimum value：8；the maximum value：40； Higher scores mean a worse outcome.
Measured: Baseline and Week 6
Change in Traditional Chinese Medicine syndromes from Baseline to 6 weeks
Traditional Chinese Medicine syndromes on days 7,14 and 42 were assessed using Traditional Chinese Medicine syndrome integral scale.Scale tittle:Traditional Chinese Medicine syndrome integral scale; The minimum value：0；the maximum value：30； Higher scores mean a worse outcome.
Measured: Baseline and Week 6
Secondary outcomes (2)
Adverse events during the treatment
The occurrence of adverse events during treatment will be recorded by telephone follow-up.
Measured: day 1 and day 14
Patients' drug compliance
Patients' drug compliance was assessed using medication possession ratio
Measured: day 1 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study startMay 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
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
- NCT06901375
- Sponsor's protocol ID
- KY20240613-11-KS-01
- Status last verified
- Jun 2024
- First submitted
- 23 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 14-day Zuojin Wan Combined with Vonoprazan-Amoxicillin Dual Therapy in the Treatment of Helicobacter Pylori Associated Chronic Gastritis:A Single-Center,Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06901375
- Acronym / sponsor ID
- KY20240613-11-KS-01
- Conditions
- Helicobacter Pylori Infection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 28 Mar 2025 (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 Zuojin Wan combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori associated chronic gastritis,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 Zuojin Wan 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. |
| Zuojin Wan ombined with vonoprazan-amoxicillin dual therapy | Experimental | Drug: Vonoprazan, Drug: Amoxicillin, Drug: Zuojin WanParticipants received Vonoprazan 20 mg tablet,Zuojin Wan 3 g tablet orally twice daily and Amoxicillin 1 g tablet orally three times daily for 10 days. |
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 liver-atomach stagnation 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 | Vonoprazan-amoxicillin dual therapy, Zuojin Wan ombined with vonoprazan-amoxicillin dual therapy |
| AmoxicillinAlso: Amoxicillin Capsules1 g tablet three times daily | Drug | Vonoprazan-amoxicillin dual therapy, Zuojin Wan ombined with vonoprazan-amoxicillin dual therapy |
| Zuojin WanAlso: Zuojin Pill3 g tablet twice daily | Drug | Zuojin Wan ombined with vonoprazan-amoxicillin dual therapy |
Primary outcome
Change from Baseline in functional dyspepsia symptoms at 6 weeks
Time frame: Baseline and Week 6
Dyspepsia symptoms on days 7,14 and 42 were assessed using Likert scale； Scale tittle:Symptom frequency and severity criteria table； The minimum value：8；the maximum value：40； Higher scores mean a worse outcome.
Change in Traditional Chinese Medicine syndromes from Baseline to 6 weeks
Time frame: Baseline and Week 6
Traditional Chinese Medicine syndromes on days 7,14 and 42 were assessed using Traditional Chinese Medicine syndrome integral scale.Scale tittle:Traditional Chinese Medicine syndrome integral scale; The minimum value：0；the maximum value：30； Higher scores mean a worse outcome.
2 secondary outcomes
Adverse events during the treatment
Time frame: day 1 and day 14
Patients' drug compliance
Time frame: day 1 and day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
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 contact
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 Early Phase 1 study testing Vonoprazan, Amoxicillin and Zuojin Wan 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: status not confirmed, as of the sponsor's last update on 28 Mar 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjuan Wei, Doctorate (+8618851009006, wjwei.hf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in functional dyspepsia symptoms at 6 weeks (time frame: Baseline and Week 6). The study lists 2 primary outcomes in all. 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 28 Mar 2025.