Helicobacter pylori infection
Conditions
Interventions
Experiment:Compound Bismuth Potassium Citrate Capsules, Omeprazole Magnesium Enteric-coated Tablets
Control:Bismuth potassium citrate, amoxicillin and clarithromycin combined omeprazole magnesium enteric-coated metformin hydrochloride
Sponsors
First affiliated hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 65 years old, male or female; 2. Gastric mucosa biopsy, rapid urease test (RUT) and breath test (It cannot be inclusive if one of this two items is negative; It cannot be inclusive if the breath test result is 4-6/1000, or unless the rechecked res ult is more than 4/1000 after 7 days) are positive, a definite diagnosis of Hp infection has been made; 3. The diagnosis of simple active duodenal ulcer has be confirmed define by gastroscopy (The size of the ulcer is between 3mm to 15mm, the ulcer number is not more than 2, the ulcers are non linear and frost-spot shape ulcer); 4. Patients who participated in the test and signed the informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients have history of stomach surgery: partial gastrectomy, gastroplasty, vagotomy (But the patient had a surgery of simple ulcer perforation repair or ulcer suture hemostasis can be inclusive); 2. Patients who have esophageal diseases (Esophageal erosions and ulcers) or combine with gastric ulcer; 3. Pregnant or lactating women, or childbearing age women who did not use reliable contraceptive measures; 4. Patients who cannott avoide alcohol during the clinic trial; 5. Patients who have serious primary diseases of liver, kidney, heart, brain, lung, endocrine system or hematopoietic system which failed to control effectively; 6. Patients who have clinical significance hepatic and renal dysfunction (Transaminase is 1.5 times greater than the upper limit of normal, or Serum creatinine is greater than the upper limit of normal), liver diseases or anaemia (Hb less than 90 g/L); 7. Patients who have contraindication to the experimental drugs: metronidazole (Active nervous system diseases, hemopathy, uncured thyroid hypofunction, uncured adrenal cortex insufficiency or intemperance); Tetracycline (Allergic to tetracycline class); Clarithromycin (Allergic to macrolides,used astemizole, cisapride, pimozide, terfenadine); Amoxicillin (Allergic to penicillin class); Omeprazole Magnesium Enteric-coated Tablets (allergic to omeprazole); 8. Patients who used antibiotics, bismuth agents (More than 3 times a week) or other experimental drugs in 30 days before recruiting; 9. Patients who need Anticoagulation therapy or long-term treatment with NSAIDS; 10. The subjects who have dysphagia; 11. Patients who had standard treatment to eradicate Hp infection before recruiting; 12. Patients who used anti-ulcer agents (Including H2-receptor blocking agent, sucralfate, misoprostol and proton pump inhibitor (PPI)) in two weeks before recruiting; 13. Patients who have Zollinger-Ellison syndrome; 14. Patients who have malignant tumor; 15. The ones who participated in other clinical trials in 3 months before recruiting; 16. In addition to the above, patients who investigator donnot think they fit to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eradication rate; | — |
Countries
China
Contacts
Public ContactNonghua Lu
Outcome results
None listed