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

NCT06901375 | Not Yet Recruiting Early Phase 1

• 1 other identifier: KY20240613-11-KS-01
• Study Type: interventional
• Target: 136
• 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 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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and Week 6

Secondary Outcomes (2)

• Adverse events during the treatment

  day 1 and day 14

• Patients' drug compliance

  day 1 and day 14

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

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.

Drug: Vonoprazan; Drug: Amoxicillin; Drug: Zuojin Wan

Interventions

Vonoprazan DRUG

20 mg tablet twice daily

Also known as: Vonoprazan fumarate

Vonoprazan-amoxicillin dual therapy; Zuojin Wan ombined with vonoprazan-amoxicillin dual therapy

Amoxicillin DRUG

1 g tablet three times daily

Also known as: Amoxicillin Capsules

Vonoprazan-amoxicillin dual therapy; Zuojin Wan ombined with vonoprazan-amoxicillin dual therapy

Zuojin Wan DRUG

3 g tablet twice daily

Also known as: Zuojin Pill

Zuojin Wan ombined with 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 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.

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; zuojin

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

Central Study Contacts

Wenjuan Wei, Doctorate

CONTACT

+8618851009006; wjwei.hf@hotmail.com

Wanli Liu, Doctorate

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 28, 2025
• Study Start: May 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 28, 2025

Record last verified: 2024-06

Locations

CN (1)