Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 4

Conditions: Glomerulonephritis; Proteinuria

Treatments: Drug: Losartan potassium 100mg; Drug: Shenyankangfu tablets; Drug: Losartan potassium 50mg; Drug: Shenyankangfu tablets and Losartan potassium 100mg; Drug: Shenyankangfu tablets and Losartan potassium 50mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02063100

S2013-055-03

Details and patient eligibility

About

-Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of patients with primary glomerulonephritis compare with Losartan potassium.

Enrollment: 720 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

• Diagnosed with primary glomerulonephritis
• Aged from 18 to 70 years，male or female
• Blood pressure can be controlled ≤140/90mmHg
• GFR≥45ml/min/1.73㎡
• 0.5g≤24 hours proteinuria≤3.0g
• 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
• Take the glucocorticoid,immunosuppressants and Tripterygium drug in the last 12 months
• Take other Chinese patent medicine and decoction which can reduce proteinuria in the last 2 weeks
• Take renin-angiotensin system blockers in last 4 weeks
• 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
• Allergic predisposition or known to be allergic to the drug composition
• Blood presser <90/60mmHg
• With unilateral or bilateral renal artery stenosis
• With mental disorders and poor compliance
• Be suspected or confirmed with alcohol, drug abuse history
• Be participating in another clinical study at the same period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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720 participants in 5 patient groups

Shenyankangfu tablets and Losartan potassium 100mg

Experimental group

Treatment:

Drug: Shenyankangfu tablets and Losartan potassium 100mg

Shenyankangfu tablets and Losartan potassium 50mg

Experimental group

Treatment:

Drug: Shenyankangfu tablets and Losartan potassium 50mg

Losartan potassium 50mg

Experimental group

Treatment:

Drug: Losartan potassium 50mg

Shenyankangfu tablets

Experimental group

Treatment:

Drug: Shenyankangfu tablets

Losartan potassium 100mg

Experimental group

Treatment:

Drug: Losartan potassium 100mg