ShuGanJieYuJiaoNang

第一阶段：探索不同剂量舒肝解郁胶囊用于广泛性焦虑障碍（肝郁脾虚证）的有效性和安全性。 第二阶段：进一步验证舒肝解郁胶囊治疗广泛性焦虑障碍的有效性和安全性。

This trial was a multi-center, randomized, double-blind, two-stage clinical trial in patients with generalized anxiety disorder (TCM differentiated as liver Qi stagnation and spleen deficiency syndrome), consisting of a exploratory study(stage 1) and a confirmatory study(stage 2).
In stage 1, 120 subjects were enrolled and randomly assigned to high-dose group, low-dose group and placebo group at a ratio of 1:1:1.
In stage 2, 440 subjects (final sample size was re-estimated based on the results of stage 1) were randomly assigned to the experimental and placebo groups at a ratio of 1:1.