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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.
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. One of urea breath test,rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 13 and 17.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test,rapid urease test or helicobacter pylori stool antigen test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| berberine , amoxicillin and rabeprazole triple therapy | Experimental | Berberine 300mg three time daily for 14days, amoxicillin 1000 mg and rabeprazole 10 mg by mouth, twice daily for 14 days. |
|
| Bismuth-containing Quadruple Therapy | Active Comparator | amoxicillin 1000 mg,clarithromy 500mg,rabeprazole 10 mg, and Bismuth 220mg by mouth, twice daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine | Drug | berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ,rabeprazole 10 mg BID. |
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication | The primary end point of this study is H.pylori eradication,established by negative urea breath test,rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment. | 28 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| symptoms effective rate | Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective rate =(total score before treatment - total score after treatment)/total score before treatment x 100%. Total score = frequency + severity. Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hosipital of Digestive Disease | Xi'an | Shaanxi | 710032 | China |
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| Amoxicillin | Drug | berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ,rabeprazole 10 mg BID. |
|
|
| Rabeprazole | Drug | berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ,rabeprazole 10 mg BID. |
|
|
| Amoxicillin | Drug | Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ,clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID |
|
|
| Clarithromycin | Drug | Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ,clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID |
|
|
| Rabeprazole | Drug | Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ,clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID |
|
|
| Bismuth | Drug | Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ,clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID |
|
| 14 days of treatment, and 28 days after treatment |
| adverse events | Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain. | 14 days of treatment, and 28 days after treatment |
| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D001599 | Berberine |
| D000658 | Amoxicillin |
| D064750 | Rabeprazole |
| D017291 | Clarithromycin |
| D001729 | Bismuth |
| ID | Term |
|---|---|
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |
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