Efficacy, safety and response predictors of adjuvant astragalus for diabetic kidney disease (READY): study protocol of an add-on, assessor-blind, parallel, pragmatic randomised controlled trial

Kam Wa Chan, Alfred Siu Kei Kwong, Pun Nang Tsui, Simon Chi Yuen Cheung, Gary Chi Wang Chan, Wing Fai Choi, Wai Han Yiu, Yanbo Zhang, Michelle Man Ying Wong, Zhang Jin Zhang, Kathryn Choon Beng Tan, Lixing Lao, Sydney Chi Wai Tang*

*Corresponding author for this work

Research output: Contribution to journalJournal articlepeer-review

7 Citations (Scopus)

Abstract

Introduction: Diabetic kidney disease (DKD) is a prevalent and costly complication of diabetes with limited therapeutic options, being the leading cause of end-stage kidney disease in most developed regions. Recent big data studies showed that add-on Chinese medicine (CM) led to a reduced risk of end-stage kidney disease and mortality among patients with chronic kidney disease (CKD) and diabetes. Astragalus, commonly known as huang-qi, is the most prescribed CM or used dietary herb in China for diabetes and DKD. In vivo and in vitro studies showed that astragalus ameliorated podocyte apoptosis, foot process effacement, mesangial expansion, glomerulosclerosis and interstitial fibrosis. Nevertheless, the clinical effect of astragalus remains uncharacterised. This pragmatic clinical trial aims to evaluate the effectiveness of add-on astragalus in patients with type 2 diabetes, stage 2–3 CKD and macroalbuminuria, and to identify related response predictors.

Methods and analysis: This is an add-on, assessor-blind, parallel, pragmatic randomised controlled clinical trial. 118 patients diagnosed with DKD will be recruited and randomised 1:1 to receive 48 weeks of add-on astragalus or standard medical care. Primary endpoints are the changes in estimated glomerular filtration rate and urine albumin-to-creatinine ratio between baseline and treatment endpoint. Secondary endpoints include adverse events, fasting blood glucose, glycated haemoglobin, lipids and other biomarkers. Adverse events are monitored through self-complete questionnaire and clinical visits. Outcomes will be analysed by regression models. Subgroup and sensitivity analyses will be conducted for different epidemiological subgroups and statistical analyses. Enrolment started in July 2018.
Original languageEnglish
Article number042686
Number of pages8
JournalBMJ Open
Volume11
Issue number1
DOIs
Publication statusPublished - 12 Jan 2021

Scopus Subject Areas

  • Medicine(all)
  • Complementary and alternative medicine
  • Endocrinology, Diabetes and Metabolism
  • Nephrology
  • Epidemiology

User-Defined Keywords

  • clinical trials
  • complementary medicine
  • diabetes & endocrinology
  • diabetic nephropathy & vascular disease
  • nephrology

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