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| Name | Class |
|---|---|
| Peking University International Hospital | OTHER |
| Beijing Geriatric Hospital | OTHER |
| Beijing Changping Integrative Medicine Hospital | UNKNOWN |
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This is an open-label, randomized controlled trial. The aim of the study is to evaluate the efficacy and safety of the Qingre Huashi Granules combined the modified dual therapy (or called high dose dual therapy) for Helicobacter pylori infection specifically in geriatric patients, compared with the bismuth containing quadruple therapy. A total of 160 eligible patients will be enrolled in 4 hospitals. The eradication rate, symptoms, and the adverse events will be recorded and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QHD group | Experimental | Qingre Huashi Granules 1 package twice daily, Rabeprazole 20mg triple daily, Amoxycillin 1g triple daily. The duration is 14 days. |
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| Control group | Active Comparator | Rabeprazole 20mg twice daily, bismuth potassium citrate 220mg twice daily, Amoxycillin 1g twice daily, clarithromycin 500mg twice daily. The duration is 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qingre Huashi Granules combined the modified dual therapy | Drug | Qingre Huashi Granules combined the modified dual therapy for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication rate | At the 4th week after the treatment, the 13-carbon urease test was conducted to evaluate the eradication condition. The value of "delta over baseline" <4 was considered to be successful eradication. | The 4th week after the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 7-point Global Overall Symptom Scale | The 7-point Global Overall Symptom Scale was used to record and evaluate the symptoms. The scale value ranges from 7 to 56. The higher scale means the worse outcome. | Baseline, the second and sixth week after the treatment, respectively. |
| Efficacy Scale of the Dampness-heat syndrome |
| Measure | Description | Time Frame |
|---|---|---|
| CYP2C19 Genotype | Failed cases will receive the CYP2C19 Genotype test. | The sixth week after the treatment. |
| Helicobacter pylori antibody test. | The antibody of anti-UREA, anti-UREB, anti-CagA, and anti-VacA was tested. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HUI YE, Doctor | Contact | +86010 83572351 | brightleaf723@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Bismuth containing quadruple therapy | Drug | Bismuth containing quadruple therapy for 14 days |
|
The Scale of the Dampness-heat syndrome was used to record and evaluate the symptoms related to the Traditional Chinese Medicine symptoms. The scale value ranges from 0 to 24. The higher scale means the worse outcome. |
| Baseline, the second and sixth week after the treatment, respectively. |
| Adverse events rate | Any adverse event related to the drugs will be recorded during the entire follow-up period. | During the follow-up, up to 6 weeks. |
| Baseline |
| Beijing Changping Integrative Medicine Hospital | Active, not recruiting | Beijing | Beijing Municipality | China |
| Peking University International Hospital | Active, not recruiting | Beijing | Beijing Municipality | China |