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Context Generalized anxiety disorder (GAD) is one of the most common anxiety disorders.It has been indicated in previous studies that Jiuwei Zhenxin Keli is effective and safe to treat GAD.Objective The primary objective of this study is to evaluate the effect and side-effects for the treatment of GAD in widely use conditions, and in order to accumulate research data and experience for improvement of the dosage regimen.Methods A single-center,open, phase Ⅳ trial evaluated the effect on patients with GAD.Twenty participants were diagnosed with GAD took part in the study.Clinical data was obtained at the outset of a period of exacerbation (t0).Jiuwei Zhenxin Keli (6g/3bags/day) was administrated orally at patients home.HAMA, HAMD-17 and CM examinations were made after 7 (tl), 14 (t2), 28 (t3) and 42 days (t4).SF-36 healthy examination was performed at the t0 and t4.We evaluated decrease in the overall score and influence made by the treatment on the patients.Result According to the objective of trial, 20 participants accomplished the entire study, and all of information was recorded by researcher.Compared with scores at start point (CM:13.50± 2.17, HAMA:19.80± 4.64,HAMD-17:14.80± 2.25), that of the end point (CM:4.70± 1.64, HAMA:6.50± 1.65, HAMD-17:4.30± 0.82) has a significant deduction (P<0.01).Whats more, the effective rate was gradually increased, at the end point (42 days), the effective rate reached 90%.Conclusion: In this study, significant differences between pre-treatment and post-treatment were observed.In conclusion, for treatment of GAD, Jiuwei Zhenxin Keli is effective and safe.