Objective To evaluate the clinical effectiveness and safety of Jiu Wei Lv Ping particle in the treatment of generalized anxiety disorder (GAD). Methods The multi-center, randomized double-blind method was used to observe 227 GAD patients who were divided into the treatment group (n=114, treated with Jiu Wei Lv Ping particle 6 g, three times a day) and the control group (n=113, treated with buspirone 10 mg, three times a day). HAMD score, and CGI-GI score were used to evaluate the clinical efficacy. TESS score and the list of symptom-recording were used to observe the safety. All the outcomes for evaluation before and after treatment at week 1, week 2, week 3 and week 4. Results According to intention-to-treat analysis (ITT), the level of decrease of HAMA score from baseline at each observational point of the treatment group was similar to that of the control group (t test, Pgt;0.05). At the end point, the effective rate of treatment group was 87.72％, and the effective rate of the control group was 87.61%. There was no significant difference between the two groups (CMH test, Pgt;0.05). According to the score of CGI-GI at each observational point, there was no difference of the effective rate between the treatment group and the control group (student test, Pgt;0.05). The side effect rate of the treatment group was 16.67%, The frequent symptoms were thirst (8.77%), dizziness (7.02%), nausea (2.63%), constipation (2.63%) and diarrhea (1.75%). The side effect rate of the control group was 30.97%, The frequent symptoms were thirst (15.04%), constipation (6.19%), nausea (4.42%), diarrhea (4.42%), dizziness (3.45%) and tachycardia (1.77%). The side effect of the treatment group was lower than that of the control group. But there was no significant difference between the two groups according to the score of TESS (F test, Pgt;0.05). Conclusions The therapeutic action of Jiu Wei Lv Ping particle in the treatment of GAD is affirmed with less side effects. It is valuable to use clinically.