Glomerulonephritis | Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis
Glomerulonephritis research study
What is the primary objective of this study?
-Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of patients with primary glomerulonephritis compare with Losartan potassium.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Shenyankangfu tabletsShenyankangfu tablets 2.4g, po, 3/day and Losartan potassium placebo 2 tab, po, 1/day,all drugs and placebo are taken for 48 weeks.
Drug:Losartan potassium 50mgShenyankangfu 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.
Drug:Shenyankangfu tablets and Losartan potassium 50mgShenyankangfu 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.
Drug:Shenyankangfu tablets and Losartan potassium 100mgShenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.
Drug:Losartan potassium 100mgShenyankangfu tablets placebo 5 tab, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Shenyankangfu tablets and Losartan potassium 100mg
Shenyankangfu tablets and Losartan potassium 50mg
Losartan potassium 50mg
Losartan potassium 100mg
Start Date: February 2014
Phase: Phase 4
Primary Outcome: changes of 24 hours proteinuria after the treatment
Secondary Outcome: changes of serum creatinine after treatment
Study sponsors, principal investigator, and references
Principal Investigator: xiangmei chen, Doctor
Lead Sponsor: Chinese PLA General Hospital
Collaborator: Tianjin TongRenTang Group Co., Ltd.