Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

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

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

Study Overview

• Status: Unknown
• Conditions: Proteinuria; Glomerulonephritis
• Intervention / Treatment: Drug: Shenyankangfu tablets and Losartan potassium 100mg; Drug: Shenyankangfu tablets and Losartan potassium 50mg; Drug: Losartan potassium 50mg; Drug: Shenyankangfu tablets; Drug: Losartan potassium 100mg

• Study Type: Interventional
• Enrollment (Anticipated): 720
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
    • Beijing, Beijing, China, 100853
      • Recruiting
      • National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
      • Contact: jie wu, doctor; Email: wujie301@163.com
      • Principal Investigator: xiangmei chen, doctor
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Friendship,Capital Medical University
    • Beijing, Beijing, China
      • Not yet recruiting
      • Xiyuan Hospital CACMS
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • Daping Hospital,Research Institute of Surgery Third Military Medical University
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fuzhou General Hospital Nanjing Military Command
    • Xiamen, Fujian, China
      • Recruiting
      • 174th hospital of the People's Liberation Army
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangzhou First People's Hospital
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Province Hospital of Chinese Medical
  • Hebei
    • Qinhuangdao, Hebei, China
      • Recruiting
      • Beidaihe Sanatorium of Beijing Military Mrca
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Third Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • Heilongjiang University of Chinese Medicine
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial People's Hospital
  • Hunan
    • Changsha, Hunan, China
      • Not yet recruiting
      • The Second Xiangya Hospital of Central South University
    • Changsha, Hunan, China
      • Recruiting
      • The Third Xiangya Hospital of Central South University
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Jiangsu Province Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • Jiangxi Provincil People'S Hospital
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The Second Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China
      • Recruiting
      • First Affilated Hospital of Dalian Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • Xijing Hospital
    • Xi'an, Shaanxi, China
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shaanxi, China
      • Recruiting
      • Tangdu Hospital
    • Xi'an, Shaanxi, China
      • Recruiting
      • Shaanxi Traditional Chinese Medicine Hospital
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Province Hospital
    • Jinan, Shandong, China
      • Recruiting
      • Teaching Hospital of Shandong University of Traditional Chinese Medicine
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Changhai Hospital of Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • LONGHUA Hospital Shanghai University of TCM
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
    • Shanghai, Shanghai, China
      • Recruiting
      • Shugaung Hospital
    • Shanghai, Shanghai, China
      • Recruiting
      • Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine
  • Shanxi
    • Taiyuan, Shanxi, China
      • Recruiting
      • First Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China
      • Recruiting
      • Shanxi Provincial People's Hospital
    • Taiyuan, Shanxi, China
      • Recruiting
      • Second Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China
      • Recruiting
      • Shanxi Hospital of Integrated Traditional and Westem Medicine
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • General Hospital of Chengdu Military Region of PLA
    • Chengdu, Sichuan, China
      • Recruiting
      • Teaching Hospital of Chengdu University of T.C.M
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China
      • Recruiting
      • First Teaching Hospital of Tianjin University of TCM
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Tongde Hospital of Zhejiang Province
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Hangzhou hospital of traditional Chinese medicine
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Provncial People'S Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shenyankangfu tablets and Losartan potassium 100mg	Drug: 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.
Experimental: Shenyankangfu tablets and Losartan potassium 50mg	Drug: 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.
Experimental: Losartan potassium 50mg	Drug: 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.
Experimental: Shenyankangfu tablets	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.
Experimental: Losartan potassium 100mg	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes of 24 hours proteinuria after the treatment	0,4,8,12,24,36,48 weeks after the enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Tianjin TongRenTang Group Co., Ltd.
• Investigators: Principal Investigator: xiangmei chen, Doctor, State Key Laboratory of Kidney Diseases,Chinese PLA General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 29, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: safety; proteinuria; efficacy; Glomerulonephritis; shenyankangfu tablets; Losartan Potassium
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Urological Manifestations; Urination Disorders; Nephritis; Proteinuria; Glomerulonephritis; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan
• Other Study ID Numbers: S2013-055-03