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| Name | Class |
|---|---|
| Shanghai 6th People's Hospital | OTHER |
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This is a multicenter, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis, with a planned follow-up of 48 weeks.
Previous studies have shown that cordyceps sinensis can act on several immune response pathways. Jinshuibao capsule, which is composed of fermented cordyceps sinensis powder (Cs-4) , has shown therapeutic effects in chronic kidney disease (CKD) according to small sample exploratory studies. Here, we conduct a prospective, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | basic treatment combined with Jinshuibao |
|
| Control group | Placebo Comparator | basic treatment and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jinshuibao | Drug | 6 capsules at a time, 3 times a day (tid). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of estimated glomerular filtration rate | Estimated Glomerular Filtration Rate (eGFR) will be calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) creatinine equation | Baseline to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of surem creatinine and 24-hour urine protein | Surem creatinine (Scr) will be tested by a central laboratory | Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks |
| Change of urinary protein/creatinine ratio (PCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D005921 | Glomerulonephritis |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Placebo | Drug | 6 capsules at a time, 3 times a day (tid). |
|
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Change from baseline in PCR
| Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks |
| Change of hs-CRP | Change from baseline in hs-CRP | Baseline to 24 weeks, 48 weeks |
| Change of TNF-α, IL-1β, and IL-6 | Change from baseline in TNF-α, IL-1β, and IL-6 | Baseline to 24 weeks and 48 weeks |
| Time to decline of 50% in eGFR or development of ESRD, and incidence of decline of 50% in eGFR or development of ESRD | End stage renal disease (ESRD)is defined by the need for long-term dialysis or renal transplantation, or eGFR<15ml/min | 48 weeks |
| Patients' Quality of life | Patients' Quality of life will be accessed by KDQOL-36 (Chinese Version) | Baseline to 24 weeks and 48 weeks |
| Number of rehospitalizations | Number of rehospitalizations during the follow-up period | 48 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009393 | Nephritis |