Zuojin Wan Combined with Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication

NCT ID: NCT06901375

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2025-08-31

Brief Summary

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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

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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

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vonoprazan-amoxicillin dual therapy

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

Group Type ACTIVE_COMPARATOR

Vonoprazan

Intervention Type DRUG

20 mg tablet twice daily

Amoxicillin

Intervention Type DRUG

1 g tablet three times daily

Zuojin Wan ombined with vonoprazan-amoxicillin dual therapy

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.

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

20 mg tablet twice daily

Amoxicillin

Intervention Type DRUG

1 g tablet three times daily

Zuojin Wan

Intervention Type DRUG

3 g tablet twice daily

Interventions

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Vonoprazan

20 mg tablet twice daily

Intervention Type DRUG

Amoxicillin

1 g tablet three times daily

Intervention Type DRUG

Zuojin Wan

3 g tablet twice daily

Intervention Type DRUG

Other Intervention Names

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Vonoprazan fumarate Amoxicillin Capsules Zuojin Pill

Eligibility Criteria

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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 liver-atomach stagnation 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wanli Liu, Doctorate

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

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Nanjing First Hospitai

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Wenjuan Wei, Doctorate

Role: CONTACT

+8618851009006

Wanli Liu, Doctorate

Role: CONTACT

Other Identifiers

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KY20240613-11-KS-01

Identifier Type: -

Identifier Source: org_study_id

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