title: Semi-individualised Chinese medicine treatment as an adjuvant management for diabetic nephropathy: a pilot add-on, randomised, controlled, multicentre, open-label pragmatic clinical trial.
abstract: Diabetes mellitus and diabetic nephropathy (DN) are prevalent and costly to manage. DN is the leading cause of end-stage kidney disease. Conventional therapy blocking the renin-angiotensin system has only achieved limited effect in preserving renal function. Recent observational data show that the use of Chinese medicine (CM), a major form of traditional medicine used extensively in Asia, could reduce the risk of end-stage kidney disease. However, existing clinical practice guidelines are weakly evidence-based and the effect of CM remains unclear. This trial explores the effect of an existing integrative Chinese-Western medicine protocol for the management of DN.
  
  
  
  To optimise parameters and assess the feasibility for a subsequent phase III randomised controlled trial through preliminary evaluation on the effect of an adjuvant semi-individualised CM treatment protocol on patients with type 2 diabetes with stages 2-3 chronic kidney disease and macroalbuminuria.
  
  
  
  This is an assessor-blind, add-on, randomised, controlled, parallel, multicentre, open-label pilot pragmatic clinical trial. 148 patients diagnosed with DN will be recruited and randomised 1:1 to a 48-week additional semi-individualised CM treatment programme or standard medical care. Primary end points are the changes in estimated glomerular filtration rate and spot urine albumin-to-creatinine ratio between baseline and treatment end point. Secondary end points include fasting blood glucose, glycated haemoglobin, brain natriuretic peptide, fasting insulin, C peptide, fibroblast growth factor 23, urinary monocyte chemotactic protein-1, cystatin C, nephrin, transforming growth factor-β1 and vascular endothelial growth factor. Adverse events are monitored through self-completed questionnaire and clinical visits. Outcomes will be analysed by regression models. Enrolment started in July 2015.
  
  
  
  This protocol is approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (reference number UW 14-301).
  
  
  
  NCT02488252.
authors: Division of Nephrology, Department of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.
authors: Kam Wa
authors: KW
authors: Chan
authors: Department of Medicine, Tung Wah Hospital, Hong Kong, Hong Kong.
authors: Tai Pang
authors: TP
authors: Ip
authors: Department of Family Medicine and Primary Healthcare, Queen Mary Hospital, Hong Kong, Hong Kong.
authors: Alfred Siu Kei
authors: AS
authors: Kwong
authors: Department of Medicine, Tung Wah Hospital, Hong Kong, Hong Kong.
authors: Sing Leung
authors: SL
authors: Lui
authors: Division of Nephrology, Department of Medicine, Queen Mary Hospital, Hong Kong, Hong Kong.
authors: Gary Chi Wang
authors: GC
authors: Chan
authors: Division of Epidemiology and Biostatistics, School of Public Health, The University of Hong Kong, Hong Kong, Hong Kong.
authors: Benjamin John
authors: BJ
authors: Cowling
authors: Division of Nephrology, Department of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.
authors: Wai Han
authors: WH
authors: Yiu
authors: Division of Nephrology, Department of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.
authors: Dickson Wai Leong
authors: DW
authors: Wong
authors: Division of Nephrology, Department of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.
authors: Yang
authors: Y
authors: Liu
authors: School of Chinese Medicine, The University of Hong Kong, Hong Kong, Hong Kong.
authors: Yibin
authors: Y
authors: Feng
authors: Division of Endocrinology, Department of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.
authors: Kathryn Choon Beng
authors: KC
authors: Tan
authors: Division of Nephrology, Department of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.
authors: Loretta Yuk Yee
authors: LY
authors: Chan
authors: Division of Nephrology, Department of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.
authors: Joseph Chi Kam
authors: JC
authors: Leung
authors: Division of Nephrology, Department of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.
authors: Kar Neng
authors: KN
authors: Lai
authors: Division of Nephrology, Department of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.
authors: Sydney Chi Wai
authors: SC
authors: Tang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003404:Creatinine / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003928:Diabetic Nephropathies / Q000188:drug therapy*; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006442:Glycated Hemoglobin / Q000032:analysis; D006723:Hong Kong; D006801:Humans; D055048:Integrative Medicine; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D010349:Patient Compliance; D010865:Pilot Projects; D057285:Precision Medicine; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D003404:Creatinine; D004365:Drugs, Chinese Herbal; D006442:Glycated Hemoglobin
keywords: Chinese medicine; albuminuria; clinical trial; glomerular filtration rate; pragmatic