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; Drug: Shenyankangfu tablets; Drug: Losartan potassium 50mg; Drug: Losartan potassium 100mg

• 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

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-29
• Primary Completion: 2015-07
• Last Update Posted: 2015-07-01

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

Group	Intervention	Description
Shenyankangfu tablets and Losartan potassium 100mg	Shenyankangfu tablets and Losartan potassium 100mg	-
Shenyankangfu tablets and Losartan potassium 50mg	Shenyankangfu tablets and Losartan potassium 50mg	-
Shenyankangfu tablets	Shenyankangfu tablets	-
Losartan potassium 50mg	Losartan potassium 50mg	-
Losartan potassium 100mg	Losartan potassium 100mg	-

Primary Outcome Measures

Name	Time	Method
changes of 24 hours proteinuria after the treatment	0,4,8,12,24,36,48 weeks after the enrollment

Secondary Outcome Measures

Name	Time	Method
changes of Traditional Chinese Medicine syndrome scores after the treatment	0,4,8,12,24,36,48 weeks after the enrollment
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

Trial Locations

Locations (43)

National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Friendship,Capital Medical University; 🇨🇳 Beijing, Beijing, China

Guang'anmen Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China

XIyuan Hospital CACMS; 🇨🇳 Beijing, Beijing, China

Daping Hospital,Research Institute of Surgery Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Fuzhou General Hospital Nanjing Military Command; 🇨🇳 Fuzhou, Fujian, China

174th hospital of the People's Liberation Army; 🇨🇳 Xiamen, Fujian, China

Guangdong Province Hospital of Chinese Medical; 🇨🇳 Guangzhou, Guangdong, China

Guangzhou First People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Beidaihe Sanatorium of Beijing Military Mrca; 🇨🇳 Qinhuangdao, Hebei, China

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