Qiming granule in treating type 2 diabetic kidney disease patients:study protocol for a randomized controlled trial
作者机构：College of OphthalmologyChengdu University of Traditional Chinese MedicineChengdu 610075China Chengdu Women’s and Children’s Central HospitalSchool of MedicineUniversity of Electronic Science and Technology of ChinaChengdu 611731China Ineye HospitalChengdu 610084China
出 版 物：《Traditional Medicine Research》 (TMR传统医学研究)
年 卷 期：2021年第6卷第1期
页 面：7-15页
学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学]
基 金：This study is supported by the State Administration of Traditional Medicine of China
主 题：Diabetic kidney disease Qiming granule Traditional Chinese medicine Randomized controlled trial
摘 要：Background:Diabetic kidney disease(DKD)is a chronic renal microvascular complication associated with abnormal glucose *** 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 *** view of this,we designed a randomized controlled trial to assess whether QMG is efficacious and safe in treating DKD ***: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 *** study will last for 50 weeks,including a 2-week run-in period,24 weeks of intervention,and 24 weeks of *** experimental intervention will be QMG,and the control intervention will be a *** primary outcome will be the 24h urinary albumin excretion ratio and the change in the albumin-to-creatinine *** secondary outcome will be evaluation of renal function,fundus changes,management of blood lipids,TCM symptom improvement and safety *** events will be recorded during the ***:This study is a randomized controlled trial to test the effectiveness and safety of QMG for DKD *** findings of this study will help to provide evidence-based recommendations in treating DKD *** registration:Chinese Clinical Trial Registry,*** 23 December 2012.
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