Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chen Xiangmei
• Collaborator: Tianjin TongRenTang Group Co., Ltd.

Criteria

Inclusion Criteria:

1. Diagnosed with primary glomerulonephritis or diabetic nephropathy;

2. Aged from 18 to 70 years，male or female

3. GFR≥45ml/min/1.73㎡

4. 0.5g≤24 hours proteinuria≤3.0g

5. glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy)

6. Traditional Chinese medicine syndrome conform Qi-Yin Deficiency

7. Obtain the agreement of patients or their guardians, and signed informed consent file

Exclusion Criteria:

1. Secondary nephropathy

2. People allergic to Shenyankangfu tables

3. Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life

4. Pregnant or lactating women

5. Be participating in another clinical study at the same period