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Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

Phase 4
Conditions
Proteinuria
Glomerulonephritis
Interventions
Drug: Shenyankangfu tablets and Losartan potassium 100mg
Drug: Shenyankangfu tablets and Losartan potassium 50mg
Registration Number
NCT02063100
Lead Sponsor
Chinese PLA General Hospital
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
720
Inclusion Criteria

Not provided

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Shenyankangfu tablets and Losartan potassium 100mgShenyankangfu tablets and Losartan potassium 100mg-
Shenyankangfu tablets and Losartan potassium 50mgShenyankangfu tablets and Losartan potassium 50mg-
Shenyankangfu tabletsShenyankangfu tablets-
Losartan potassium 50mgLosartan potassium 50mg-
Losartan potassium 100mgLosartan potassium 100mg-
Primary Outcome Measures
NameTimeMethod
changes of 24 hours proteinuria after the treatment0,4,8,12,24,36,48 weeks after the enrollment
Secondary Outcome Measures
NameTimeMethod
changes of Traditional Chinese Medicine syndrome scores after the treatment0,4,8,12,24,36,48 weeks after the enrollment
changes of serum creatinine after treatment0,4,8,12,24,36,48 weeks after the enrollment
changes of eGFR after the treatment0,4,8,12,24,36,48 weeks after the enrollment

Trial Locations

Locations (43)

National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital

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Beijing, Beijing, China

Beijing Friendship,Capital Medical University

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Beijing, Beijing, China

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

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Beijing, Beijing, China

XIyuan Hospital CACMS

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Beijing, Beijing, China

Daping Hospital,Research Institute of Surgery Third Military Medical University

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Chongqing, Chongqing, China

Guangdong Province Hospital of Chinese Medical

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Guangzhou, Guangdong, China

Beidaihe Sanatorium of Beijing Military Mrca

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Qinhuangdao, Hebei, China

Heilongjiang University of Chinese Medicine

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Harbin, Heilongjiang, China

Henan Provincial People'S Hospital

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Zhengzhou, Henan, China

Jiangsu Province Hospital

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Nanjing, Jiangsu, China

Jiangxi Provincil People'S Hospital

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Nanchang, Jiangxi, China

The Second Hospital of Jilin University

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Changchun, Jilin, China

First Affilated Hospital of Dalian Medical University

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Dalian, Liaoning, China

Shaanxi Traditional Chinese Medicine Hospital

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Xi'an, Shaanxi, China

The First Affiliated Hospital of Xi'An Jiaotong University

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Xi'an, Shaanxi, China

Shandong Province Hospital

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Jinan, Shandong, China

Xijing Hospital

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Xi'an, Shaanxi, China

Teaching Hospital of Shandong University of Traditional Chinese Medicine

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Jinan, Shandong, China

Changhai Hospital of Shanghai

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Shanghai, Shanghai, China

LONGHUA Hospital Shanghai University of TCM

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Shanghai, Shanghai, China

Shanghai Jiao Tong University School of Medicine

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Shanghai, Shanghai, China

Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University

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Shanghai, Shanghai, China

Shugaung Hospital

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Shanghai, Shanghai, China

Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine

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Shanghai, Shanghai, China

Second Hospital of Shanxi Medical University

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Taiyuan, Shanxi, China

General Hospital of Chengdu Military Region of PLA

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Chengdu, Sichuan, China

Teaching Hospital of Chengdu University of T.C.M

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Chengdu, Sichuan, China

First Teaching Hospital of Tianjin University of TCM

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Tianjin, Tianjin, China

Hangzhou Hospital of Traditional Chinese Medicine

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Hangzhou, Zhejiang, China

Tianjin Medical University General Hospital

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Tianjin, Tianjin, China

Tongde Hospital of Zhejiang Province

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Hangzhou, Zhejiang, China

Zhejiang Provncial People'S Hospital

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Hangzhou, Zhejiang, China

Fuzhou General Hospital Nanjing Military Command

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Fuzhou, Fujian, China

174th hospital of the People's Liberation Army

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Xiamen, Fujian, China

The Third Hospital of hebei Medical University

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Shijiazhuang, Hebei, China

The Second Xiangya Hospital of Central South University

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Changsha, Hunan, China

Guangzhou First People's Hospital

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Guangzhou, Guangdong, China

The Third Xiangya Hospital of Central South University

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Changsha, Hunan, China

Xiangya Hospital Central South University

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Changsha, Hunan, China

Tangdu Hospital

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Xi'an, Shaanxi, China

Shanxi Hospital of Integrated Traditional and Westem Medicine

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Taiyuan, Shanxi, China

Shanxi Provincial People's Hospital

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Taiyuan, Shanxi, China

First Hospital of Shanxi Medical University

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Taiyuan, Shanxi, China

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