Efficacy and safety of Taizi Shenyue Capsules in the treatment of mild to moderate depression
Objective:To evaluate the efficacy and safety of Taizi Shenyue Capsules in the treatment of mild to moderate depression.Methods:The study subjects were randomly divided into experimental group,positive drug group,and placebo group,with a treatment period of 8 weeks.Evaluation was conducted after 0,1,2,4,8 weeks of treatment with the Hamilton Depression Scale-17 items(HAMD-17)scale score reduction as the main efficacy evaluation indicators,and the safety evaluation indicators included laboratory examination,electrocardiogram examination,vital signs,and incidence of adverse events.Results:Totally 601 depression patients met the inclusion criteria.At the treatment endpoint,there was a statistically significant difference in the reduction score between the three groups(P<0.000 1).The experimental group was superior to the placebo group(P<0.000 1),while the experimental group was not inferior to the positive drug group(P =0.7354>0.05).It cannot be considered that the experimental group was superior to the positive drug group.The incidences of adverse events during the treatment period were 9.27%,15.97%,and 10.83%,respectively(P>0.05).Conclusion:Taizi Shenyue Capsules is safe and effective in treating mild to moderate depression.
mild to moderate depressionTaizi Shenyue Capsulestraditional Chinese medicine therapysafety
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