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Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Chinese herbal medicine Shenzhuo Formula treatment in patients with macroalbuminuria secondary to diabetic kidney disease: study protocol for a randomized controlled trial

Authors: Xue-min Zhao, Ying Zhang, Xin-hui He, Hong-dong Chen, Zhu-feng Wang, Jing Guo, Xin-miao Wang, Ze-zheng Gao, Ji-ping Wang, Wei Liu, Lin-hua Zhao, Xiao-lin Tong

Published in: Trials | Issue 1/2018

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Abstract

Background

Diabetic kidney disease (DKD) is a serious complication associated with diabetes mellitus and can cause end-stage renal disease (ESRD). Traditional Chinese medicine (TCM) is widely used in China to treat DKD, and in particular microalbuminuria and macroalbuminuria. This study will address the efficacy and safety of Shenzhuo Formula (SZF), a frequently prescribed TCM, in DKD patients with macroalbuminuria.

Methods/design

This study is a 24-week, randomized, multi-center, double-blinded, double-dummy, controlled, clinical trial that will include 120 DKD patients aged 18 to 80 years old with a 24-h urinary protein (24-h UP) level of between 0.5 g and 3 g and serum creatinine (SCr) ≤ 133 μmol/L (1.5 mg/dL) and compare SZF to irbesartan. The 24-h UP change from baseline to week 24 will represent the primary endpoint with secondary endpoints including SCr, estimated glomerular filtration rate (eGFR), TCM symptoms, urinary albumin excretion rate (UAER), etc. Safety assessments will also be evaluated.

Discussion

This study will provide initial evidence regarding the efficacy and safety of SZF relative to irbesartan in the treatment of DKD patients with macroalbuminuria.

Trial registration

Chinese Clinical Trial Registry, ID: ChiCTR-ICR-15006311. Registered on 15 April 2015.
Appendix
Available only for authorised users
Literature
1.
Cheng XY, Nayyar S, Wang M, Li XM, Sun Y, Huang W, et al. Mortality rates among prevalent hemodialysis patients in Beijing: a comparison with USRDS data. Nephrol Dial Transpl. 2013;28(3):724–32.CrossRef
2.
Saran R, Li Y, Robinson B. US Renal Data System 2014 Annual Data Report: Epidemiology of Kidney Disease in the United States (vol 66, pg S1, 2015). Am J Kidney Dis. 2015;66(3):545.CrossRef
3.
Lin CH, Chang YC, Chuang LM. Early detection of diabetic kidney disease: present limitations and future perspectives. World J Diabetes. 2016;7(14):290–301.CrossRefPubMedPubMedCentral
4.
Elrggal ME, Ahmed SM, El Nahas M. Renin-angiotensin-aldosterone system blockade in diabetic kidney disease: a critical and contrarian point of view. Saudi J Kidney Dis Transpl. 2016;27(6):1103–13.CrossRefPubMed
5.
de Francisco AM, Garcia-Luque A, Fernandez M, Puerro M. Side effects of angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists: are we facing a new syndrome? Am J Cardiol. 2012;110(10):1552–3.CrossRef
6.
Roberts JR, Lee JJ, Marthers DA. Angiotensin-converting enzyme (ACE) inhibitor angioedema: the silent epidemic. Am J Cardiol. 2012;109(5):774–5.CrossRefPubMed
7.
Yan M, Wen Y, Yang L, Wu X, Lu X, Zhang B, et al. Chinese herbal medicine Tangshen Formula treatment of patients with type 2 diabetic kidney disease with macroalbuminuria: study protocol for a randomized controlled trial. Trials. 2016;17(1):259.CrossRefPubMedPubMedCentral
8.
Yang S, Wang Y, Chen Z, Lv J, Wang X, Hu C, et al. Common Chinese medicine syndromes of diabetic nephropathy questionnaire-based study of experts. Chin J Integr Trad West Nephrol. 2013;14:1097–9.
9.
Zhou D, Zhao J, Mou X, Liu W, Zhou D, Liu Y, et al. Distribution of syndrome stages of diabetic nephropathy. J Beijing Univ Tradit Chin Medi Chin Med Clin Edition. 2012;19(1):38–41.
10.
Ji L, Tong X, Wang H, Tian H, Zhou H, Zhang L, et al. Efficacy and safety of traditional Chinese medicine for diabetes: a double-blind, randomised, controlled trial. PLoS One. 2013;8(2):e56703.CrossRefPubMedPubMedCentral
11.
Tong XL, Wu ST, Lian FM, Zhao M, Zhou SP, Chen XY, et al. The safety and effectiveness of TM81, a Chinese herbal medicine, in the treatment of type 2 diabetes: a randomized double-blind placebo-controlled trial. Diabetes Obes Metab. 2013;15(5):448–54.CrossRefPubMed
12.
Zhao XF, Su SJ, Guo YH, Wang S. Mortality and recurrence of vascular disease among stroke patients treated with combined TCM therapy. J Tradit Chin Med. 2012;32(2):173–8.CrossRefPubMed
13.
Tian J, Zhao L, Zhou Q, Liu W, Chen X, Lian F, et al. Efficacy of Shenzhuo formula on diabetic kidney disease: a retrospective study. J Tradit Chin Med. 2015;35(5):528–36.CrossRefPubMed
14.
Chen HD, Guo J, Zhao XM, He XH, He ZC, Zhao LH, et al. Retrospective analysis of the overt proteinuria diabetic kidney disease in the treatment of modified Shenzhuo formula for two years. Medicine. 2017;96(12):e6349.CrossRefPubMedPubMedCentral
15.
Li P, Chen YP, Liu JP, Hong J, Deng YY, Yang F, Jin XP, et al. Efficacy and safety of Tangshen Formula on patients with Type 2 diabetic kidney disease: a multicenter double-blinded randomized placebo-controlled trial. PLoS One. 2015;10(5):e0126027.CrossRefPubMedPubMedCentral
16.
Tian JX, Zhao LH, Zhou Q, Tong XL. Retrospective analysis on modified Didang Tang for treating microalbuminuria of diabetic nephropathy. Bei Jing Zhong Yi Yao Da Xue Xue Bao (Zhong Yi Lin Chuang Ban). 2012;19(6):710.
17.
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
18.
Drouin P, Blickle JF, Charbonnel B, Eschwege E, Guillausseau PJ, Plouin PF, et al. Diagnosis and classification of diabetes mellitus: the new criteria. Diabetes Metab. 1999;25(1):72–83.PubMed
19.
Assoc AD. Standards of Medical Care in Diabetes—2013. Diabetes Care. 2013;36:S11–66.CrossRef
20.
Nelson RG, Tuttle KR. The new KDOQI clinical practice guidelines and clinical practice recommendations for diabetes and CKD. Blood Purif. 2007;25(1):112–4.CrossRefPubMed
21.
National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. Am J Kidney Dis. 2012;60(5):850–86.CrossRef
22.
Zheng X. Clinical research guideline of new investigational drug in traditional Chinese medicine. Beijing: China Medical Science Press; 2002.
23.
Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150(9):604–12.CrossRefPubMedPubMedCentral
24.
He J, Du L, Liu G, Fu J, He X, Yu J, et al. Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional Chinese medicine RCTs: a review of 3159 RCTs identified from 260 systematic reviews. Trials. 2011;12:122.CrossRefPubMedPubMedCentral
25.
Cheng CW, Wu TX, Shang HC, Li YP, Altman DG, Moher D, et al. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med. 2017;167(2):W7-W20.
Metadata
Title
Chinese herbal medicine Shenzhuo Formula treatment in patients with macroalbuminuria secondary to diabetic kidney disease: study protocol for a randomized controlled trial
Authors
Xue-min Zhao
Ying Zhang
Xin-hui He
Hong-dong Chen
Zhu-feng Wang
Jing Guo
Xin-miao Wang
Ze-zheng Gao
Ji-ping Wang
Wei Liu
Lin-hua Zhao
Xiao-lin Tong
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2573-z

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