Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis
1 other identifier
interventional
720
1 country
43
Brief Summary
-Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of patients with primary glomerulonephritis compare with Losartan potassium.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 12, 2014
CompletedFirst Posted
Study publicly available on registry
February 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedJuly 1, 2015
June 1, 2015
1.4 years
February 12, 2014
June 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes of 24 hours proteinuria after the treatment
0,4,8,12,24,36,48 weeks after the enrollment
Secondary Outcomes (3)
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
Study Arms (5)
Shenyankangfu tablets and Losartan potassium 100mg
EXPERIMENTALShenyankangfu tablets and Losartan potassium 50mg
EXPERIMENTALLosartan potassium 50mg
EXPERIMENTALShenyankangfu tablets
EXPERIMENTALLosartan potassium 100mg
EXPERIMENTALInterventions
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.
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 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 2.4g, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.
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.
Eligibility Criteria
You may qualify if:
- 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㎡
- g≤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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese PLA General Hospitallead
- Tianjin TongRenTang Group Co., Ltd.collaborator
Study Sites (43)
National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Beijing Friendship,Capital Medical University
Beijing, Beijing Municipality, China
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
XIyuan Hospital CACMS
Beijing, Beijing Municipality, China
Daping Hospital,Research Institute of Surgery Third Military Medical University
Chongqing, Chongqing Municipality, 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
The Third Hospital of hebei Medical University
Shijiazhuang, Hebei, China
Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China
Henan Provincial People'S Hospital
Zhengzhou, Henan, 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
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Jiangxi Provincil People'S Hospital
Nanchang, Jiangxi, China
The Second Hospital of Jilin University
Changchun, Jilin, China
First Affilated Hospital of Dalian Medical University
Dalian, Liaoning, 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
Shandong Province Hospital
Jinan, Shandong, China
Teaching Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
LONGHUA Hospital Shanghai University of TCM
Shanghai, Shanghai Municipality, China
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Shanghai, Shanghai Municipality, China
Shugaung Hospital
Shanghai, Shanghai Municipality, China
Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 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
General Hospital of Chengdu Military Region of PLA
Chengdu, Sichuan, China
Teaching Hospital of Chengdu University of T.C.M
Chengdu, Sichuan, China
First Teaching Hospital of Tianjin University of TCM
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 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
Related Publications (2)
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.
PMID: 33589406DERIVEDKou 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.
PMID: 25480673DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
xiangmei chen, Doctor
State Key Laboratory of Kidney Diseases,Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 12, 2014
First Posted
February 14, 2014
Study Start
February 1, 2014
Primary Completion
July 1, 2015
Last Updated
July 1, 2015
Record last verified: 2015-06