Abstract：Objective：To observe the clinical effect of Xiaoke Yiqi tang combined with routine western medicine on type 2 diabetes mellitus(T2DM) with syndrome of spleen deficiency and turbid phlegm as well as deficiency of both qi and yin. Methods：A hundred T2DM patients with syndrome of spleen deficiency and turbid phlegm as well as deficiency of both qi and yin were randomly divided into two groups， 50 cases in each group. The control group was treated with gliclazide sustained release tablets and metformin enteric- coated tablets， and the observation group was additionally treated with Xiaoke Yiqi tang based on the treatment of the control group. Both groups were treated for two months. The changes in the levels of fasting blood glucose(FBG)， 2h postprandial glucose(P2hBG)， Hemoglobin A1c(HbA1c) and Chinese medicine symptom scores were measured before and after treatment in the two groups，and the overall clinical effect was compared. Results：The total effective rate was 92.00% in the observation group and 76.00% in the control group，the difference being significant(P＜0.05). After treatment，the levels of FBG，P2hBG and HbA1c in serum in the two groups were significantly decreased when compared with those before treatment(P＜0.05)，and the above levels in the observation group were lower than those in the control group(P＜0.05). After treatment，the scores of thirsty and preference to drinking，fatigue and lack of strength，frequent diets and easiness to hunger as well as short of breath and words were decreased significantly in the two groups(P＜0.05)， and the above scores in the observation group were lower than those in the control group(P＜0.05). Conclusion：The therapy of Xiaoke Yiqi tang combined with routine western medicine has significant effect on T2DM patients with syndrome of spleen deficiency and turbid phlegm as well as deficiency of both qi and yin，whose effect is better than that of western medicine alone.