Objective To observe the effect and safety of Hongjingtian [Rhodiola] capsule in treating mild or moderate major depressive disorder with deficiency of both heart and spleen. Methods Totally 220 mild or moderate major depressive disorder（ MDD） patients with deficiency of both heart and spleen syndrome were randomized into placebo group（ 73 cases）

small dose Hongjingtian group（ 73 cases） and large dose Hongjingtian group（ 74 cases）.The placebo group was given placebo 1. 2 g every day. The small dose Hongjingtian group was given Hongjingtian capsule 0. 6 g and placebo 0. 6 g every day. The large dose Hongjingtian group was given Hongjingtian capsule 1. 2 g every day. Hamilton Depression Scale（ HAMD）

Beck Depression Inventory（ BDI） and Effectiveness Index（ EI） was evaluated before and after treatment of 2

4 and 8 weeks. The safety was examined. Results The difference of HAMD score

BDI score and EI at each time point in the placebo group was not significant（ P > 0. 05）. Compared with the previous time point

HAMD score and BDI score at each time point decreased in the small and large dose Hongjingtian groups

while EI increased（ P < 0. 05）. Compared with the placebo group at the same time point

HAMD score and BDI score after treatment for 2

4 and 8 weeks decreased in the small and large dose Hongjingtian groups

while EI increased. Moreover

the improvement in the large dose Hongjingtian group was superior to that in the small dose Hongjingtian group（ P < 0. 05）. No serious side effect was found in each group. Conclusion Hongjingtian capsule might improve mild or moderate depression with good safety. The effect of dose 1. 2 g/d seemed to be superior to that of dose 0. 6 g/d.