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Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

Primary Purpose

Glomerulonephritis, Proteinuria

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Shenyankangfu tablets
Losartan potassium 50mg
Shenyankangfu tablets and Losartan potassium 50mg
Shenyankangfu tablets and Losartan potassium 100mg
Losartan potassium 100mg
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glomerulonephritis focused on measuring Glomerulonephritis, proteinuria, shenyankangfu tablets, Losartan Potassium, efficacy, safety

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General HospitalRecruiting
  • Beijing Friendship,Capital Medical UniversityRecruiting
  • Guang'anmen Hospital, China Academy of Chinese Medical SciencesRecruiting
  • XIyuan Hospital CACMS
  • Daping Hospital,Research Institute of Surgery Third Military Medical UniversityRecruiting
  • Fuzhou General Hospital Nanjing Military CommandRecruiting
  • 174th hospital of the People's Liberation ArmyRecruiting
  • Guangdong Province Hospital of Chinese MedicalRecruiting
  • Guangzhou First People's HospitalRecruiting
  • Beidaihe Sanatorium of Beijing Military MrcaRecruiting
  • The Third Hospital of hebei Medical UniversityRecruiting
  • Heilongjiang University of Chinese MedicineRecruiting
  • Henan Provincial People'S HospitalRecruiting
  • The Second Xiangya Hospital of Central South University
  • The Third Xiangya Hospital of Central South UniversityRecruiting
  • Xiangya Hospital Central South UniversityRecruiting
  • Jiangsu Province HospitalRecruiting
  • Jiangxi Provincil People'S HospitalRecruiting
  • The Second Hospital of Jilin UniversityRecruiting
  • First Affilated Hospital of Dalian Medical UniversityRecruiting
  • Shaanxi Traditional Chinese Medicine HospitalRecruiting
  • Tangdu HospitalRecruiting
  • The First Affiliated Hospital of Xi'An Jiaotong UniversityRecruiting
  • Xijing HospitalRecruiting
  • Shandong Province HospitalRecruiting
  • Teaching Hospital of Shandong University of Traditional Chinese MedicineRecruiting
  • Changhai Hospital of ShanghaiRecruiting
  • LONGHUA Hospital Shanghai University of TCMRecruiting
  • Shanghai Jiao Tong University School of MedicineRecruiting
  • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong UniversityRecruiting
  • Shugaung HospitalRecruiting
  • Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of MedicineRecruiting
  • First Hospital of Shanxi Medical UniversityRecruiting
  • Second Hospital of Shanxi Medical UniversityRecruiting
  • Shanxi Hospital of Integrated Traditional and Westem MedicineRecruiting
  • Shanxi Provincial People's HospitalRecruiting
  • General Hospital of Chengdu Military Region of PLARecruiting
  • Teaching Hospital of Chengdu University of T.C.MRecruiting
  • First Teaching Hospital of Tianjin University of TCMRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • Hangzhou Hospital of Traditional Chinese MedicineRecruiting
  • Tongde Hospital of Zhejiang ProvinceRecruiting
  • Zhejiang Provncial People'S HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Shenyankangfu tablets and Losartan potassium 100mg

Shenyankangfu tablets and Losartan potassium 50mg

Losartan potassium 50mg

Shenyankangfu tablets

Losartan potassium 100mg

Arm Description

Outcomes

Primary Outcome Measures

changes of 24 hours proteinuria after the treatment

Secondary Outcome Measures

changes of serum creatinine after treatment
changes of eGFR after the treatment
changes of Traditional Chinese Medicine syndrome scores after the treatment

Full Information

First Posted
February 12, 2014
Last Updated
June 29, 2015
Sponsor
Chinese PLA General Hospital
Collaborators
Tianjin TongRenTang Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02063100
Brief Title
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Tianjin TongRenTang Group Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, Proteinuria
Keywords
Glomerulonephritis, proteinuria, shenyankangfu tablets, Losartan Potassium, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shenyankangfu tablets and Losartan potassium 100mg
Arm Type
Experimental
Arm Title
Shenyankangfu tablets and Losartan potassium 50mg
Arm Type
Experimental
Arm Title
Losartan potassium 50mg
Arm Type
Experimental
Arm Title
Shenyankangfu tablets
Arm Type
Experimental
Arm Title
Losartan potassium 100mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Shenyankangfu tablets
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Losartan potassium 50mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Shenyankangfu tablets and Losartan potassium 50mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Shenyankangfu tablets and Losartan potassium 100mg
Intervention Description
Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Losartan potassium 100mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes of 24 hours proteinuria after the treatment
Time Frame
0,4,8,12,24,36,48 weeks after the enrollment
Secondary Outcome Measure Information:
Title
changes of serum creatinine after treatment
Time Frame
0,4,8,12,24,36,48 weeks after the enrollment
Title
changes of eGFR after the treatment
Time Frame
0,4,8,12,24,36,48 weeks after the enrollment
Title
changes of Traditional Chinese Medicine syndrome scores after the treatment
Time Frame
0,4,8,12,24,36,48 weeks after the enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jie wu, doctor
Phone
+86-010-66937763
Email
wujie301@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
jia kou, doctor
Email
chinakoujia@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiangmei chen, Doctor
Organizational Affiliation
State Key Laboratory of Kidney Diseases,Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jie wu, doctor
Email
wujie301@163.com
First Name & Middle Initial & Last Name & Degree
xiangmei chen, doctor
Facility Name
Beijing Friendship,Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
XIyuan Hospital CACMS
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Daping Hospital,Research Institute of Surgery Third Military Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Name
Fuzhou General Hospital Nanjing Military Command
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Name
174th hospital of the People's Liberation Army
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Province Hospital of Chinese Medical
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Beidaihe Sanatorium of Beijing Military Mrca
City
Qinhuangdao
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Hospital of hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Provincial People'S Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangxi Provincil People'S Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Name
First Affilated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
Shaanxi Traditional Chinese Medicine Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xi'An Jiaotong University
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Province Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Teaching Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
LONGHUA Hospital Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Shugaung Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Hospital of Integrated Traditional and Westem Medicine
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
General Hospital of Chengdu Military Region of PLA
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Teaching Hospital of Chengdu University of T.C.M
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
First Teaching Hospital of Tianjin University of TCM
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Name
Hangzhou Hospital of Traditional Chinese Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Tongde Hospital of Zhejiang Province
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Provncial People'S Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
33589406
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.
Results Reference
derived
PubMed Identifier
25480673
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.
Results Reference
derived

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Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

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