Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

Proteinuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02063100
• Other study ID #: S2013-055-03
• Status: Recruiting
• Phase: Phase 4
• First received: February 12, 2014
• Last updated: June 29, 2015
• Start date: February 2014

Study information

• Verified date: June 2015
• Source: Chinese PLA General Hospital
• Contact: jie wu, doctor
• Phone: +86-010-66937763
• Email: wujie301[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis
• Proteinuria

Intervention

Drug:
• Shenyankangfu 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.
• Losartan potassium 50mg
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.
• Shenyankangfu 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.
• Shenyankangfu 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.
• Losartan potassium 100mg
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.

Locations

Country	Name	City	State
China	Beijing Friendship,Capital Medical University	Beijing	Beijing
China	Guang'anmen Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing
China	National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital	Beijing	Beijing
China	XIyuan Hospital CACMS	Beijing	Beijing
China	The Second Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	General Hospital of Chengdu Military Region of PLA	Chengdu	Sichuan
China	Teaching Hospital of Chengdu University of T.C.M	Chengdu	Sichuan
China	Daping Hospital,Research Institute of Surgery Third Military Medical University	Chongqing	Chongqing
China	First Affilated Hospital of Dalian Medical University	Dalian	Liaoning
China	Fuzhou General Hospital Nanjing Military Command	Fuzhou	Fujian
China	Guangdong Province Hospital of Chinese Medical	Guangzhou	Guangdong
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Hangzhou Hospital of Traditional Chinese Medicine	Hangzhou	Zhejiang
China	Tongde Hospital of Zhejiang Province	Hangzhou	Zhejiang
China	Zhejiang Provncial People'S Hospital	Hangzhou	Zhejiang
China	Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang
China	Shandong Province Hospital	Jinan	Shandong
China	Teaching Hospital of Shandong University of Traditional Chinese Medicine	Jinan	Shandong
China	Jiangxi Provincil People'S Hospital	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Beidaihe Sanatorium of Beijing Military Mrca	Qinhuangdao	Hebei
China	Changhai Hospital of Shanghai	Shanghai	Shanghai
China	LONGHUA Hospital Shanghai University of TCM	Shanghai	Shanghai
China	Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University	Shanghai	Shanghai
China	Shugaung Hospital	Shanghai	Shanghai
China	Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	The Third Hospital of hebei Medical University	Shijiazhuang	Hebei
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Shanxi Hospital of Integrated Traditional and Westem Medicine	Taiyuan	Shanxi
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	First Teaching Hospital of Tianjin University of TCM	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Shaanxi Traditional Chinese Medicine Hospital	Xi'an	Shaanxi
China	Tangdu Hospital	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'An Jiaotong University	Xi'an	Shaanxi
China	Xijing Hospital	Xi'an	Shaanxi
China	174th hospital of the People's Liberation Army	Xiamen	Fujian
China	Henan Provincial People'S Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Tianjin TongRenTang Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of 24 hours proteinuria after the treatment		0,4,8,12,24,36,48 weeks after the enrollment	No
Secondary	changes of serum creatinine after treatment		0,4,8,12,24,36,48 weeks after the enrollment	No
Secondary	changes of eGFR after the treatment		0,4,8,12,24,36,48 weeks after the enrollment	No
Secondary	changes of Traditional Chinese Medicine syndrome scores after the treatment		0,4,8,12,24,36,48 weeks after the enrollment	No