Qiming granule in treating type 2 diabetic kidney disease patients: study protocol for a randomized controlled trial

Background: Diabetic kidney disease (DKD) is a chronic renal microvascular complication associated with abnormal glucose metabolism. According to traditional Chinese medicine (TCM) theory, Qi and Yin deficiency with blood stasis (the name of TCM symptoms, its main clinical features are fatigue, dry mouth, red or pale tongue, weak pulse, etc.) is the primary TCM syndrome of DKD, and Qiming granule (QMG) is suitable for the treatment of Qi and Yin deficiency with blood stasis syndrome. In view of this, we designed a randomized controlled trial to assess whether QMG is efficacious and safe in treating DKD patients. Methods: This protocol is for a randomized, double-blind, placebo-controlled, parallel group, six-centre clinical trial. A total of 180 participants will be randomized into the QMG group or placebo group, with a 1:1 ratio. The study will last for 50 weeks, including a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The experimental intervention will be QMG, and the control intervention will be a placebo. The primary outcome will be the 24h urinary albumin excretion ratio and the change in the albumin-to-creatinine ratio. The secondary outcome will be evaluation of renal function, fundus changes, management of blood lipids, TCM symptom improvement and safety assessments. Adverse events will be recorded during the trial. Discussion: This study is a randomized controlled trial to test the effectiveness and safety of QMG for DKD patients. The findings of this study will help to provide evidence-based recommendations in treating DKD patients. Trial registration: Chinese Clinical Trial Registry, ChiCTR-TRC-12002953. Registered 23 December 2012.