Abstract: OBJECTIVE To explore the clinical effects of Ningxin Anshen Granules in the treatment of patients with generalized anxiety disorder (GAD) of blood deficiency and liver heat type， and its impacts on serum inflammatory factors. METHODS 60 patients with generalized anxiety disorder (blood deficiency and liver heat type) were selected. A randomized， double blind placebo control was used as control. The treatment course was 4 weeks. The observation group was intervened by orally taking Ningxin Anshen Granules， and the control group was intervened by orally taking placebo granules. Both groups were taking 1 dose/d， warm taking at morning and evening. Clinical effects， levels of inflammatory factors IL-1β， IL-6， TNF-α， interferon-γ (IFN-γ)， cortisol (CS) and prostaglandin E₂ (PGE₂)， and adverse reactions in two groups were observed and compared. RESULTS The total effect of the observation group was 83.33%， which was significantly higher than that of the control group (40%) (P<0.01). Comparing with the control group， the changes of IL-1β， IL-6， TNF-α， CS and PGE₂ in the observation group were significant (P<0.05，P<0.01). However， there was no statistical difference in IFN-γ among groups(P>0.05). There was one case of adverse reactions in the observation group and two cases in the control group， and there was no significant difference between the two groups (P>0.05). CONCLUSION Ningxin Anshen Formula can effectively improve the anxiety symptoms of GAD patients， relieve inflammatory response with few adverse reactions and favorable compliance.