Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection

Study Overview
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Brief Summary
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This study is to evaluate the efficacy and safety of the Jinghua Weikang Capsule (a Chinese patent medicine for peptic ulcer and gastritis) containing quadruple therapy (Jinghua Weikang Caplsule plus triple therpy) for eradicating Helicobacter pylori in IgA nephropathy.

Official Title
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The Effect and Safety of Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection, a Randomized Pilot Study

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: JWC containing quadruple therapy
* Drug: Bismuth-containing quadruple therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IgA nephropathy diagnosed by renal biopsy; Current Helicobacter pylori infection; Age 18-65. Exclusion Criteria: ①eGFR<90ml/（min·1.73m2）- History of Helicobacter pylori treatment Present taking hormones or immunosuppressants Malignant tumor and high-grade intraepithelial neoplasia and severe dysplasia of gastric mucosa Allergy history to medicines used in the study History of gastric surgery Uncontrolled chronic diseases such as diabetes, cardiovascular and cerebrovascular diseases, respiratory diseases, mental disorders and other researchers are considered to affect treatment and assessment Combined with other primary or secondary nephropathy except for IgAN Combined with acute renal injury Female patients with pregnancy, lactation and planned pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: JWC group<br>Jinghua Weikang Capsule containing quadruple therapy. | Drug: JWC containing quadruple therapy<br>* Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days.<br>|
| Active Comparator: Control group<br>Bismuth-containing quadruple therapy. | Drug: Bismuth-containing quadruple therapy<br>* Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradicaion rate | The Helicobacter pylori infection status was measured by 13-carbon breath test. | The forth week after the treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood creatinine level | The change of average blood creatinine level between two groups. | Baseline, the third and sixth month after the treatment, respectively. | 
| Blood urea nitrogen level | The change of average blood urea nitrogen level between two groups. | Baseline, the third and sixth month after the treatment, respectively. | 
| eGFR | The change of average eGFR level between two groups. | Baseline, the third and sixth month after the treatment, respectively. | 
| 24hrs urine protein level | The change of average24hrs urine protein level between two groups. | Baseline, the third and sixth month after the treatment, respectively. | 
| Blood presure | The change of average blood presure level between two groups. | Baseline, the third and sixth month after the treatment, respectively. | 
| IgA level | The change of average IgA level level between two groups. | Baseline, the third and sixth month after the treatment, respectively. | 
| IgA1 level | The change of average IgA1 level between two groups. | Baseline, the third and sixth month after the treatment, respectively. | 
| Gd-IgA1 level | The change of average Gd-IgA1 level level between two groups. | Baseline, the third and sixth month after the treatment, respectively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, IgA nephropathy, Jinghua Weikang Caplsule, Bismuth-containing quadruple therapy, Eradication