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Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical efficiency and safety of Zuojin Wan combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori associated chronic gastritis,through a randomized controlled trail.
Helicobacter pylori(H.pylori)is a gastric pathogen, related to various gastrointestinal disorders. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Vonoprazan and high-dose amoxicillin dual therapy is a potential H.pylori eradication regimen. It provides a satisfactory eradication rate of 90%. Nevertheless,it has certain limitations, including a series of problems such as low eradication rate and more side effects of eradication in recurrent patients. The main side effects of the dual therapy for eradication are related symptoms of gastric motility deficiency and indigestion, such as bloating, abdominal pain, belching, acid reflux, etc. Combining traditional Chinese medicine may be one of the effective ways to solve the above problems.This study aims to compare the efficacy of Zuojin Wan combined with vonoprazan and high-dose amoxicillin dual therapy,with that of vonoprazan and high-dose amoxicillin dual therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonoprazan-amoxicillin dual therapy | Active Comparator | Participants received Vonoprazan 20 mg tablet orally twice daily and Amoxicillin 1 g tablet orally three times daily for 2 weeks. |
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| Zuojin Wan ombined with vonoprazan-amoxicillin dual therapy | Experimental | Participants received Vonoprazan 20 mg tablet,Zuojin Wan 3 g tablet orally twice daily and Amoxicillin 1 g tablet orally three times daily for 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | 20 mg tablet twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in functional dyspepsia symptoms at 6 weeks | Dyspepsia symptoms on days 7,14 and 42 were assessed using Likert scale; Scale tittle:Symptom frequency and severity criteria table; The minimum value:8;the maximum value:40; Higher scores mean a worse outcome. | Baseline and Week 6 |
| Change in Traditional Chinese Medicine syndromes from Baseline to 6 weeks | Traditional Chinese Medicine syndromes on days 7,14 and 42 were assessed using Traditional Chinese Medicine syndrome integral scale.Scale tittle:Traditional Chinese Medicine syndrome integral scale; The minimum value:0;the maximum value:30; Higher scores mean a worse outcome. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events during the treatment | The occurrence of adverse events during treatment will be recorded by telephone follow-up. | day 1 and day 14 |
| Patients' drug compliance | Patients' drug compliance was assessed using medication possession ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjuan Wei, Doctorate | Contact | +8618851009006 | wjwei.hf@hotmail.com | |
| Wanli Liu, Doctorate | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Wanli Liu, Doctorate | Nanjing First Hospital, Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospitai | Nanjing | Jiangsu | 210006 | China |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D000658 | Amoxicillin |
| C545320 | zuojin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Amoxicillin | Drug | 1 g tablet three times daily |
|
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| Zuojin Wan | Drug | 3 g tablet twice daily |
|
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| day 1 and day 14 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |