Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection

Study Overview
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Brief Summary
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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.

Official Title
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Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection Treatment in the Elderly Patient, a Multi-center, Randomized, Controlled Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Qingre Huashi Granules combined the modified dual therapy
* Drug: Bismuth containing quadruple therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current Helicobacter pylori infection. Age ≥ 60 years. Diagnosed with syndrome of dampness-heat by Traditional Chinese Medicine. Signed the informed consent document. Exclusion Criteria: History of Helicobacter pylori treatment. History of gastric surgery. Allergic to any medications involved in the intervention. Sever complications, such as lung dysfunction, uncontrolled hypertension, diabetes, cardiovascular disease, renal dysfunction (eGFR<60ml/min'1.73m2) , malignant tumor，mental disorder. Taking medications that may be conflict to the intervention drugs. Failing to express symptoms, unwilling to cooperate. Taking any antibiotics within a month.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QHD group<br>Qingre Huashi Granules 1 package twice daily, Rabeprazole 20mg triple daily, Amoxycillin 1g triple daily. The duration is 14 days. | Drug: Qingre Huashi Granules combined the modified dual therapy<br>* Qingre Huashi Granules combined the modified dual therapy for 14 days<br>|
| Active Comparator: Control group<br>Rabeprazole 20mg twice daily, bismuth potassium citrate 220mg twice daily, Amoxycillin 1g twice daily, clarithromycin 500mg twice daily. The duration is 14 days. | Drug: Bismuth containing quadruple therapy<br>* Bismuth containing quadruple therapy for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Geriatic, Dual therapy, Bismuth-containing quadruple therapy, Qingre Huashi Decoction