Title
Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis
Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis-a Multicentre, Prospective, Double-blind, Double-dummy, Randomized Controlled Clinical Trial
Phase
Phase 4Lead Sponsor
People's Liberation Army of ChinaStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Glomerulonephritis ProteinuriaIntervention/Treatment
shenyankangfu losartan ...Study Participants
720-Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of patients with primary glomerulonephritis compare with Losartan potassium.
Shenyankangfu tablets 2.4g, po, 3/day and Losartan potassium placebo 2 tab, po, 1/day,all drugs and placebo are taken for 48 weeks.
Shenyankangfu tablets placebo 5 tab, po, 3/day and losartan potassium 50mg,po, 1/day and losartan potassium placebo1 tab,po, 1/day, all drugs and placebo are taken for 48 weeks.
Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg,po, 1/day and losartan potassium placebo1 tab, po, 1/day, all drugs and placebo are taken for 48 weeks.
Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.
Shenyankangfu tablets placebo 5 tab, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.
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
