Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

Chen Xiangmei

Status and phase: Unknown; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Drug: Shenyan Kangfu Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT02885857

S2015-023-02

Details and patient eligibility

About

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

Full description

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,500 participants in 1 patient group

Shenyan kangfu Tablets

Experimental group

Description:

Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day

Treatment:

Drug: Shenyan Kangfu Tablet