Status:
COMPLETED
Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Helicobacter Pylori Infection
Chronic Gastritis
Eligibility:
All Genders
17-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of the triple therapy of berberine hydrochloride, vonorasan and amoxicillin for the primary eradication of Helicobacter pylori.It is h...
Detailed Description
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent....
Eligibility Criteria
Inclusion
- Age between 18\~70,both gender.
- Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
- Patients are willing to receive eradication treatment.
- Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.
Exclusion
- Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
- Patients with contraindications or allergies to the study drug.
- Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
- Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
- Pregnant or lactating women.
- Underwent upper gastrointestinal Surgery.
- Patients with moderate to severe dysplasia or high degree of intraepithelial neoplasia.
- Patients have symptom of dysphagia.
- Evidence of bleeding or iron efficiency anemia.
- A history of malignancy.
- Drug or alcohol abuse history in the past 1 year.
- Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
- Patients who has psychological problem or poor compliance.
- Enrolled in other clinical trials in the past 3 months.
- Refuse to sign informed consent.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2025
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT06514274
Start Date
September 20 2024
End Date
June 25 2025
Last Update
July 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China, 710032