Objective To observe the therapeutic effect of Qiyao Xiaoke Capsule [capsule of Huangqi （Radix Astragali） and Shanyao （Rhizoma Dioscoreae） for dispersion-thirst ] for diabetic nephropathy.Methods The multicenter

r andomized

double-blind and placebo control experiments were adopted in this study.Totally 224cases of diabetic nephropathy were ob-served and randomized into the trial group and placebo control group

with 146and 78in each.Both groups were given routine therapy.The trial group was given Qiyao Xiaoke Capsule in addition.The treatment lasted for 12weeks.The Chinese medicine syndrome efficacy

disappearance rate of Chinese medicine mono-symptom

blood sugar

blood lipid and renal function were compared after treatment.Results The Chinese medicine syndrome efficacy in the trial group and placebo control group was 85.62%and 70.51%respectively

with a significant difference between groups （P<0.05）.The disappearance rates of Chinese medicine mono-symptom in the trial group were significantly higher than those in the placebo control group except for red uri-nate

hypochondriac pain

limb pain and forgetfulness （P<0.05）.Both groups were significantly improved in blood sugar and lipid after treatment （P<0.05or P<0.01）.There was no significant difference between groups in the fasting glucose and 2h postprandial blood glucose （P>0.05）.Comparing with the placebo control group

the glycosylated hemoglobin

triglycerides

total cholesterol and low density lipoprotein-C were significantly improved in the trial group （P<0.05）.Conclusion Qiyao Xiaoke Capsule can regulate glucose and lipid metabolism and improve blood urea nitrogen

serum creatinine

glomerular filtra-tion rate

urinary albumin excretion and urine protein quantity for diabetes

with a better protective effect on the kidney.