Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis
NCT ID: NCT02063100
Last Updated: 2015-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
720 participants
INTERVENTIONAL
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Shenyankangfu tablets and Losartan potassium 100mg
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.
Shenyankangfu tablets and Losartan potassium 50mg
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.
Losartan potassium 50mg
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
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 100mg
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Tianjin TongRenTang Group Co., Ltd.
UNKNOWN
Chinese PLA General Hospital
OTHER
Responsible Party
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Chen Xiangmei
Professor
Principal Investigators
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xiangmei chen, Doctor
Role: PRINCIPAL_INVESTIGATOR
State Key Laboratory of Kidney Diseases,Chinese PLA General Hospital
Locations
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National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
Beijing, Beijing Municipality, 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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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S2013-055-03
Identifier Type: -
Identifier Source: org_study_id
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