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Objective To observe the clinical efficacy and safety of Morinda Officinalis Oligose Capsule in the treatment of functional dyspepsia (FD) accompanied by mild-to-moderate depression，and to investigate its possible action mechanism. Methods The randomized control study was adopted，120 cases of FD accompanied by mild-to-moderate depression were randomly assigned into the trial group (48 cases)，control group (40 cases) and placebo group (32 cases) .The three groups were respectively given Morinda Officinalis Oligose Capsule，escitalopram and placebo for 6 weeks. The Hamilton Depression Scale-17 (HAMD-17) and the Gastrointestinal Symptom Score (GIS) were adopted to evaluate the depression degree and digestive tract symptoms. The plasma 5-hydroxytryptamine (5-HT) level before and after treatment were compared among the three groups. Results Compared with before treatment，the HAMD-17 score，GIS score and plasma 5-HT level after treatment in the trial group and control group were significantly decreased with statistical difference (P <0.05) . Compared with the placebo group，the HAMD-17 score，GIS score and plasma 5-HT level after treatment in the trial group and control group were decreased，the differences were statistically significant (P<0.05) ，while comparing the trial group with the control group，the difference had no statistical significance (P>0.05) . The occurrence rate of adverse reactions was 16.67% in the trial group，22.50% in the control group and 21.88% in the placebo group，the difference had no statistical significance (P >0.05) . Conclusion Morinda Officinalis Oligose Capsule can significantly ameliorate the depression disoder and digestive tract symptoms in FD patients accompanied by mild-tomoderate depression， its effect is similar to that of escitalopram and adverse reactions are similar to placebo， its good clinical effect may have a certain correlation with decreasing the plasma 5-HT level. [ABSTRACT FROM AUTHOR]