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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 Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori infection complicated with functional dyspepsia,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 Banxiaxiexin decoction 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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| Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy | Experimental | Participants received Vonoprazan 20 mg tablet orally twice daily,Amoxicillin 1 g tablet and Banxiaxiexin decoction 100 ml liquid-medicine orally three times daily for 2 weeks. |
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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 |
|---|---|---|
| Helicobacter pylori eradication rate | Eradication of H. pylori is assessed by a 13C-urea breath test (13C-UBT) performed 4 weeks after completion of eradication therapy (at week 6). A negative 13C-UBT result indicates successful eradication. | At 4 weeks post-treatment (week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspeptic symptom score | Dyspeptic symptoms (epigastric pain, epigastric burning, postprandial fullness, early satiation) are assessed using a 4-point Likert scale for both frequency and severity. Frequency is graded as 0 (none), 1 (1-2 days/week for pain/burning; 3 days/week for fullness/satiation), 2 (3-4 days/week for pain/burning; 4-5 days/week for fullness/satiation), or 3 (≥5 days/week for pain/burning; 6-7 days/week for fullness/satiation). Severity is graded as 0 (none), 1 (mild, does not affect daily activities), 2 (moderate, can be tolerated but partially affects daily activities), or 3 (severe, difficult to tolerate and significantly affects daily activities). The total symptom score is calculated as the sum of (frequency score × severity score) for each symptom, with a possible range from 0 to 36. Higher scores indicate worse dyspeptic symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
| 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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| Banxiaxiexin decoction | Drug | 100 ml liquid-medicine twice daily |
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| Baseline (week 0), immediately after 2-week treatment (week 2), and at follow-up (week 6) |
| Incidence of adverse events | Adverse events occurring during the treatment period are recorded via telephone follow-up. The incidence and type of adverse events are documented. | During the 2-week treatment period (days 1-14) |
| Medication adherence rate | Medication adherence is evaluated using the medication possession ratio (MPR). MPR is calculated as (actual number of doses taken / expected number of doses) × 100%. Good adherence is defined as MPR ≥80%; poor adherence as MPR <80%. | During the 2-week treatment period (days 1-14) |
| Tongue coating microbiota composition | Tongue coating samples are collected at baseline (week 0), after 2-week treatment (week 2), and at follow-up (week 6). Samples are obtained by swabbing a 2 cm × 2 cm area on the dorsal tongue surface with a sterile cotton swab after rinsing with saline. Samples are stored at -80 °C for subsequent 16S rRNA sequencing to analyze changes in microbiota composition and diversity. | Baseline (week 0), week 2, and week 6 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |