Clinical trial NCT02063100: Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis
Official title: Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis-a Multicentre, Prospective, Double-blind, Double-dummy, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glomerulonephritis
Proteinuria
Keywords: Glomerulonephritis
proteinuria
shenyankangfu tablets
Losartan Potassium
efficacy
safety
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin TongRenTang Group Co., Ltd.
First posted: 2014-02-14
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: changes of 24 hours proteinuria after the treatment
timeFrame: 0,4,8,12,24,36,48 weeks after the enrollment
Secondary outcomes:
measure: changes of serum creatinine after treatment
timeFrame: 0,4,8,12,24,36,48 weeks after the enrollment
measure: changes of eGFR after the treatment
timeFrame: 0,4,8,12,24,36,48 weeks after the enrollment
measure: changes of Traditional Chinese Medicine syndrome scores after the treatment
timeFrame: 0,4,8,12,24,36,48 weeks after the enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: XIyuan Hospital CACMS
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital,Research Institute of Surgery Third Military Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fuzhou General Hospital Nanjing Military Command
state: Fujian
city: Xiamen
country: China
facility: 174th hospital of the People's Liberation Army
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Chinese Medical
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Qinhuangdao
country: China
facility: Beidaihe Sanatorium of Beijing Military Mrca
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital of hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People'S Hospital
state: Henan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincil People'S Hospital
state: Jiangxi
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: First Affilated Hospital of Dalian Medical University
state: Liaoning
city: Xi'an
country: China
facility: Shaanxi Traditional Chinese Medicine Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'An Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
city: Jinan
country: China
facility: Shandong Province Hospital
state: Shandong
city: Jinan
country: China
facility: Teaching Hospital of Shandong University of Traditional Chinese Medicine
state: Shandong
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: LONGHUA Hospital Shanghai University of TCM
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
state: Shanghai
city: Shanghai
country: China
facility: Shugaung Hospital
state: Shanghai
city: Shanghai
country: China
facility: Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Hospital of Integrated Traditional and Westem Medicine
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Chengdu
country: China
facility: General Hospital of Chengdu Military Region of PLA
state: Sichuan
city: Chengdu
country: China
facility: Teaching Hospital of Chengdu University of T.C.M
state: Sichuan
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of TCM
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Hangzhou Hospital of Traditional Chinese Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Tongde Hospital of Zhejiang Province
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provncial People'S Hospital
state: Zhejiang
Study officials:
affiliation: State Key Laboratory of Kidney Diseases,Chinese PLA General Hospital
name: xiangmei chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu J, Duan SW, Yang HT, Deng YY, Li W, He YN, Ni ZH, Zhan YL, Lin S, Guo ZY, Zhu J, Fang JA, Liu XS, Wang LH, Wang R, Wang NS, Cheng XH, He LQ, Luo P, Sun SR, Sun JF, Yin AP, Jiang GR, Chen HY, Liu WH, Lin HL, Liang M, Ma L, Chen M, Song LQ, Chen J, Zhu Q, Xing CY, Li Y, Gao JN, Li RS, Li Y, Zhang H, Lu Y, Zhou QL, Fu JZ, He Q, Cai GY, Chen XM. Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial. J Integr Med. 2021 Mar;19(2):111-119. doi: 10.1016/j.joim.2021.01.009. Epub 2021 Jan 30.
citation: Kou J, Wu J, Yang HT, He YN, Fang JA, Deng YY, Xie YS, Nie LF, Lin HL, Cai GY, Chen XM. Efficacy and safety of Shenyankangfu tablets for primary glomerulonephritis: study protocol for a randomized controlled trial. Trials. 2014 Dec 5;15:479. doi: 10.1186/1745-6215-15-479.