Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

Study Overview
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Brief Summary
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Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.

Detailed Description
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Research purpose: Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease. The crowd: patients with primary glomerular nephritis, diabetic nephropathy patients. Study design: a multicenter clinical study design, openness. The study drug: Shenyan Kangfu Tablets. Statistical analysis: Research plan is determined, by statistical professionals responsible for negotiation with the principal investigator for statistical analysis plan.

Official Title
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Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: Shenyan Kangfu Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with primary glomerulonephritis or diabetic nephropathy; Aged from 18 to 70 years，male or female GFR≥45ml/min/1.73㎡ 0.5g≤24 hours proteinuria≤3.0g glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy) Traditional Chinese medicine syndrome conform Qi-Yin Deficiency Obtain the agreement of patients or their guardians, and signed informed consent file Exclusion Criteria: Secondary nephropathy People allergic to Shenyankangfu tables Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life Pregnant or lactating women Be participating in another clinical study at the same period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shenyan kangfu Tablets<br>Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day | Drug: Shenyan Kangfu Tablet<br>* Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urinary protein excretion |  | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine |  | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times | 
| Glomerular filtration rate |  | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times | 
| Albumin |  | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times | 
| Glycated hemoglobin | Observations of the project value and the percentage change in value before and after the treatment. | Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times | 
| Symptom scores |  | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times |