Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

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

Official Title
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Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis-a Multicentre, Prospective, Double-blind, Double-dummy, Randomized Controlled Clinical Trial

Conditions
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Glomerulonephritis, Proteinuria

Intervention / Treatment
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* Drug: Shenyankangfu tablets
* Drug: Losartan potassium 50mg
* Drug: Shenyankangfu tablets and Losartan potassium 50mg
* Drug: Shenyankangfu tablets and Losartan potassium 100mg
* Drug: Losartan potassium 100mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shenyankangfu tablets and Losartan potassium 100mg<br> | Drug: Shenyankangfu tablets and Losartan potassium 100mg<br>* Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.<br>|
| Experimental: Shenyankangfu tablets and Losartan potassium 50mg<br> | Drug: Shenyankangfu tablets and Losartan potassium 50mg<br>* 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.<br>|
| Experimental: Losartan potassium 50mg<br> | Drug: Losartan potassium 50mg<br>* 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.<br>|
| Experimental: Shenyankangfu tablets<br> | Drug: Shenyankangfu tablets<br>* 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.<br>|
| Experimental: Losartan potassium 100mg<br> | Drug: Losartan potassium 100mg<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of 24 hours proteinuria after the treatment |  | 0,4,8,12,24,36,48 weeks after the enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glomerulonephritis, proteinuria, shenyankangfu tablets, Losartan Potassium, efficacy, safety