[Translation] A randomized, double-blind, double-dummy, parallel-controlled, multicenter clinical trial on the efficacy and safety of Shujiele Granules in the treatment of mild and moderate depression (liver depression syndrome)
在Ⅱa期探索性临床试验基础上,选择舒解乐颗粒大剂量(每次10g)与氟西汀及安慰剂对照,以汉密顿抑郁量表(HAMD)积分减少值为主要疗效指标,进一步评价舒解乐颗粒治疗轻、中度抑郁症(肝郁证)的有效性及安全性,为Ⅲ期临床试验提供依据。
[Translation] Based on the Phase IIa exploratory clinical trial, a large dose of Shujiele Granules (10g each time) was selected for comparison with fluoxetine and placebo, and the reduction in Hamilton Depression Rating Scale (HAMD) points was used as the primary efficacy indicator to further evaluate the effectiveness and safety of Shujiele Granules in the treatment of mild and moderate depression (liver depression syndrome), providing a basis for Phase III clinical trials.