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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| Ruijin Hospital | OTHER |
| Shanghai 6th People's Hospital | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
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The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics.
The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics. Combined with TCM Syndrome research, the investigators will clarify targets or mechanisms of herbal treatment. Eventually, to form a more clinically appropriate standardized combination treatment of severe IgA nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WM Group | Experimental | Shentong Granules, two packs, bid, P.O., 48weeks; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months |
|
| Hormone Group | Placebo Comparator | Placebo ; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WM (Shentong Granules) | Drug | Shentong Granules with Prednisone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular filtration rate | changes from Baseline to 2, 4, 12, 24,36 and 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour urinary protein excretion | changes from Baseline to 2, 4, 12, 24,36 and 48 weeks | |
| serum creatinine | changes from Baseline to 2, 4, 12, 24,36 and 48 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueyi Deng, MD. | Contact | +86-021-64385700-3226 | dengyueyi@medmail.com.cn | |
| Wanjia Chen, MS. | Contact | +86-021-64385700-3222 | wdgzkj@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology,Longhua Hospital | 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 |
|---|---|
| D006728 | Hormones |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| OTHER |
| Fudan University | OTHER |
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| Hormone (prednisone) | Drug | Oral prednisone |
|
|
| serum Lipid |
| Half-yearly |
| TCM syndrome score | changes from Baseline to 2, 4, 12, 24,36 and 48 weeks |
| 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 |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |