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| Name | Class |
|---|---|
| Shanghai 6th People's Hospital | OTHER |
| RenJi Hospital | OTHER |
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IgA nephropathy(IgAN) is the highest incidence of kidney pathology in the primary nephropathy. In terms of differences in prognosis, severe IgA nephropathy,one of the most main primary renal disease,could cause the uremia. It will be significant that early indicators of prognosis and early intervention can be normalized and the scientific criteria for judging the efficacy of great clinical can be established. The subject based on the past study,literature research and various treatment will take the method of multi-center, double-blind, randomized, control to investigate the standard treatment of severe IgA nephropathy. Otherwise the uniformity and objectivity of Traditional Chinese Medicine (TCM) will be improved by the standardization of TCM research based on the epidemiological investigation and statistical analysis. The subject will determine the efficacy of more sensitive biomarkers and establish more scientific criteria for judging the effect with the application of urine proteomics and metabolomics technologies in order to operate in the formation of the standardization program of the treatment of severe IgA nephropathy with the Integrative medicine of TCM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Group | Experimental | Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg·d, po. 48weeks |
|
| Placebo | Placebo Comparator | Placebo of Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg•d, po. 48weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese Herb Prescription Granule plus prednisone | Drug | Chinese Herb Prescription Granule includes ZiBuGanShen Granule and BuShenTongLuo Granule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular filtration rate | Evaluation of renal function indicators | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hours urine protein | Evaluate the therapeutic effect | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YUEYI DENG, Dr. | Contact | 64385700 | 3222 | lhkidney@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| YueYi Deng, PHD,MD | Shanghai University of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology,Longhua Hospital | Recruiting | Shanghai | 200032 | China |
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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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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | Placebo includes placebo of ZiBuGanShen Granule and placebo of BuShenTongLuo Granule |
|
| 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 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |