Glomerulonephritis, Proteinuria
Conditions
Keywords
Glomerulonephritis, proteinuria, shenyankangfu tablets, Losartan Potassium, efficacy, safety
Brief summary
-Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of patients with primary glomerulonephritis compare with Losartan potassium.
Interventions
DRUGShenyankangfu tablets
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.
DRUGShenyankangfu tablets and Losartan potassium 50mg
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.
DRUGShenyankangfu tablets and Losartan potassium 100mg
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.
Sponsors
Tianjin TongRenTang Group Co., Ltd.
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes of 24 hours proteinuria after the treatment | 0,4,8,12,24,36,48 weeks after the enrollment |
Secondary
| Measure | Time frame |
|---|---|
| changes of serum creatinine after treatment | 0,4,8,12,24,36,48 weeks after the enrollment |
| changes of eGFR after the treatment | 0,4,8,12,24,36,48 weeks after the enrollment |
| changes of Traditional Chinese Medicine syndrome scores after the treatment | 0,4,8,12,24,36,48 weeks after the enrollment |
Countries
China
Contacts
Primary Contactjie wu, doctor
Backup Contactjia kou, doctor
Outcome results
None listed