Efficacy, Safety and Response Predictors of Adjuvant Astragalus Therapy for Diabetic Kidney Disease
Summary
This add-on open-label randomised controlled pragmatic trial aims to: 1. evaluate the effect of add-on astragalus treatment on type 2 diabetic patients with stage 2 to 3 chronic kidney disease and macroalbuminuria. 2. estimate treatment effect, variance, recruitment rate, attrition rate and change in clinical manifestation including Chinese medicine syndrome for parameters optimisation and feasibility assessment for a subsequent phase III randomised controlled trial. 3. assess response predictors for efficacy and safety among type 2 diabetic patients with stage 2 to 3 chronic kidney disease and macroalbuminuria receiving add-on astragalus treatment
Timeline
- Start
- 2018-07-01
- Primary completion
- 2022-06-30
- Completion
- 2022-12-31
Outcome
Mixed primary results
paper the estimated difference in the slope of eGFR decline was 4.6 ml/min/1.73m2 per year (95 %CI: 1.5 to 7.6, p = 0.003) slower with astragalus. PMID 38810556 ↗
paper For UACR, the estimated inter-group proportional difference in the slope of change was insignificant (1.14, 95 %CI: 0.85 to 1.52, p = 0.392). PMID 38810556 ↗
Publications
- Chan KW, Kwong ASK, Tsui PN, Chan GCW, Choi WF, Yiu WH, Cheung SCY, Wong MMY, Zhang ZJ, Tan KCB, Lao L, Lai KN, Tang SCW; READY and SCHEMATIC research group. Add-on astragalus in type 2 diabetes and chronic kidney disease: A multi-center, assessor-blind, randomized controlled trial. Phytomedicine. 2024 Jul 25;130:155457. doi: 10.1016/j.phymed.2024.155457. Epub 2024 Feb 28.
- Chan KW, Kwong ASK, Tsui PN, Cheung SCY, Chan GCW, Choi WF, Yiu WH, Zhang Y, Wong MM, Zhang ZJ, Tan KCB, Lao L, Tang SCW. 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. BMJ Open. 2021 Jan 12;11(1):e042686. doi: 10.1136/bmjopen-2020-042686.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Astragalus Powder | Traditional medicine (herbal / TCM) | 3 g | Oral |