Clinical trial · Interventional
Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy
Efficacy and Safety of Berberine Hydrochloride, Amoxicillin and Rabeprazole Triple Therapy in the First Eradication of Helicobacter Pylori
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims at evaluating efficacy and safety of berberine hydrochloride, amoxicillin and rabeprazole triple therapy versus bismuth-containing quadruple therapy(amoxicillin, clarithromycin, rabeprazole and bismuth) in the first eradication treatment of H. pylori. It is hypothesized that berberinehydrochloride, amoxicillin and rabeprazole triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test,rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Gastritis | — | UNRESOLVED | — |
| Dyspepsia | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Helicobacter Pylori Infection | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amoxicillin | Drug | — | UNRESOLVED |
| Berberine | Drug | — | UNRESOLVED |
| Bismuth | Drug | — | UNRESOLVED |
| Clarithromycin | Drug | — | UNRESOLVED |
| Rabeprazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- berberine , amoxicillin and rabeprazole triple therapy
- description
- Berberine 300mg three time daily for 14days, amoxicillin 1000 mg and rabeprazole 10 mg by mouth, twice daily for 14 days.
- interventionNames
- Drug: Berberine
- Drug: Amoxicillin
- Drug: Rabeprazole
- type
- ACTIVE_COMPARATOR
- label
- Bismuth-containing Quadruple Therapy
- description
- amoxicillin 1000 mg,clarithromy 500mg,rabeprazole 10 mg, and Bismuth 220mg by mouth, twice daily for 14 days.
- interventionNames
- Drug: Amoxicillin
- Drug: Clarithromycin
- Drug: Rabeprazole
- Drug: Bismuth
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18\~70,both gender. 2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment; 3. Patients are willing to receive eradication treatment. 4. Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial. Exclusion Criteria: 1. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori. 2. Patients with contraindications or allergies to the study drug. 3. Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases. 4. 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). 5. Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma. 6. Pregnant or lactating women. 7. Underwent upper gastrointestinal Surgery. 8. Patients with moderate to severe dysplasia or high degree of intraepithelial neoplasia. 9. Patients have symptom of dysphagia. 10. Evidence of bleeding or iron efficiency anemia. 11. A history of malignancy. 12. Drug or alcohol abuse history in the past 1 year. 13. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). 14. Patients who has psychological problem or poor compliance. 15. Enrolled in other clinical trials in the past 3 months. 16. Refuse to sign informed consent.
References
Publications (0)
Data not yet available