Status:
COMPLETED
Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Bismuth-containing Quadruple Therapy
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Gastritis
Peptic Ulcer
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This study aims at evaluating efficacy and safety of berberine-containing quadruple therapy(berberine, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismut...
Detailed Description
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signatur...
Eligibility Criteria
Inclusion
- Age between 18\~70,both gender.
- Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
- Patients are willing to receive eradication treatment.
- Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.
Exclusion
- Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
- Contraindications to study drugs.
- Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
- 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)
- Pregnant or lactating women.
- Underwent upper gastrointestinal Surgery.
- Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
- Evidence of bleeding or iron eficiency 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).
- Enrolled in other clinical trials in the past 3 months.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
612 Patients enrolled
Trial Details
Trial ID
NCT02296021
Start Date
November 1 2014
End Date
September 1 2015
Last Update
September 3 2015
Active Locations (1)
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1
Xijing Hospital of Digestive Diseases
Xi’an, Shanxi, China, 710032