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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JWC group | Experimental | Jinghua Weikang Capsule containing quadruple therapy. |
|
| Control group | Active Comparator | Bismuth-containing quadruple therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JWC containing quadruple therapy | Drug | Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HUI YE | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38299639 | Derived | Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3. |
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IPD will be shared on https://clinicaltrials.gov.
The data will be uploaded within 6 month after Dec 31, 2024.
The user of ClinicalTrials.gov PRS could access the data.
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Bismuth-containing quadruple therapy | Drug | Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days. |
|
| 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |