The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao Capsule on diabetic kidney disease in T2DM patients.
Diabetic Kidney Disease (DKD) is one of the most important microvascular complications of diabetes and is the leading cause of end-stage renal disease. Intensive glycemic and blood pressure control, combined with renin - angiotensin system blocking therapy (including ACEI and ARB drugs), has to a certain extent, delayed the progression of DKD, but still cannot completely block its development. Cordyceps sinensis is a traditional Chinese medicine and Jinshuibao Capsule is its artificial preparation, with the effect of renoprotection. However, its clinical application in diabetic kidney disease is not well-defined so far. The aim of this study is to investigate the potential use of Jinshuibao Capsule on microalbuminuria in T2DM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
1.98g t.i.d. p.o. for 6 months
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Change in urine albumin creatine ratio (ACR).
First morning urine (10-15ml) of the subject is collected with a clean urine collection tube (or vial).
Time frame: Baseline and 1,2,3,6 months.
The incidence of ≧30% decline in eGFR from baseline.
Monitoring changes in glomerular functions measured in estimated glomerular filtration rate (eGFR) \[CKD-EPI creatinine-cystatin equation (2012)\].
Time frame: half a year
Change in urine α1-microglobulin.
Time frame: Baseline and 1,2,3,6 months.
Change in urine β2-microglobulin.
Time frame: Baseline and 1,2,3,6 months.
Change in urine N-acetyl-β-D-glucosidase.
Time frame: Baseline and 1,2,3,6 months.
Change in urine neutrophil gelatinase-associated lipocalin.
Time frame: Baseline and 1,2,3,6 months.
Change in inflammation level.
Change in hs-CRP level.
Time frame: Baseline and 1,2,3,6 months.
Change in HbA1c.
Time frame: Baseline and 1,3,6 months.
Change in blood pressure control.
Time frame: Baseline and 1,2,3,6 months.
Change in blood lipids.
Time frame: Baseline and 1,3,6 months.
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Life quality evaluation
Change in SF-36 Scale score.
Time frame: Baseline and 6 months.
Incidence of Treatment-Emergent Adverse Events
Treatment-related adverse events as assessed by deterioration of liver functions with other reasons excluded, self-report of gastrointestinal symptoms associated with drug intake, etc.
Time frame: half a year