ABSTRACT:OBJECTIVE To explore the clinical efficacy and safety of Chailong Jieyu pill in treating generalized anxiety dis-order(Stagnation of liver qi syndrome).METHODS A six-week randomized,double-blind,placebo-controlled study was con-ducted on 60 patients with the diagnosis of generalized anxiety disorder(Stagnation of liver qi syndrome).The treatment group took Chailong Jieyu pill orally,every 6g,3 times a day.And then Hamiltonanxietyscale (HAMA),TCMsymptomcustom-scale,Side reaction scale(TESS) were observed.RESULTS The score of HAMA and TCM symptom custom scale in the treatment group had a significant and progressive effect(P <0.01),and were better than that in the control group(P <0.01) after 2 weeks,4 weeks and 6 weeks.For HAMA,the total effective rate of the treatment group was 93.10%,better than that of the control group which was 32.26%(P <0.01).For TCM symptom custom scale,the total effective rate of the treatment group was 93.10%,better than that of the control group which was 29.03% (P <0.01).The every score of TCM symptom custom scale in the treatment group had significant differences after treatment(P <0.01),while score in the control group on-ly had a statistic significance on the symptom of irritability(P <0.05).The comparison between the groups had a significant difference on the symptoms of irritability,sigh,palpitation and dizziness(P <0.01).The score of TESS had no statistic sig-nificance(P >0.05).CONCLUSION Chailong Jieyu Pill is effective and safe and has little side effect,high compliance in treating generalized anxiety disorder(Stagnation of liver qi syndrome).