Objective To observe the therapeutic effect of Qiyao Xiaoke Capsule（Capsule for Diabetes） on the diabetes type Ⅱ.Methods Totally 240 diabetes type Ⅱ patients were randomized into a treatment group（n=150）

and a control group（n=90）;and other 30 diabetes patients who didn’t regularly take hypoglycemic drugs were set as opening group.The treatment group was administered Qiyao Xiaoke Capsule plus Metformin Hydrochloride Tablets

while the control group was prescribed Xiaokeling Capsule in addition to Metformin Hydrochloride Tablets

and the opening group was given Qiyao Xiaoke Capsule only

with a leading period of two weeks.The patients were treated for 4 weeks.Before treatment and at the end of the 4 weeks’ treatment

the fasting blood glucose（FBG）

2 hours postprandial blood glucose（2hPG）

and glycosylated hemoglobin（HbA1c） of all groups were determined

and scores of TCM syndromes and symptoms were observed to evaluate the therapeutic effect.Results The total effective rate of the treatment group was 74.67%

of the control group 72.22%

and in the opening group 70.00%.Except for the 2hPG of the opening group

the FBG

2hPG and HbA1c of 3 groups were decreased（P<0.05 or P<0.01）.In the treatment group

except for deep-colored urine and constipation

all other symptoms were significantly relieved（P<0.05）

compared with those of the control and opening groups

the difference was significant（P<0.05）.Conclusion Qiyao Xiaoke Capsule is effective in decreasing the blood glucose and relieving the symptoms of diabetics type Ⅱ.