Clinical Study Of Morinda Officinals Oligose Capsule In The Treatment Of Depression

Objective:Fluoxetine as control drugs, to evaluate the efficacy and safety of Morinda officinalis oligose capsule in the treatment of mild and moderate depressive disorder(kidney deficiency syndrome).Methods:In a randomized, doubl-e-blind, double-dummy, multicenter, variable dose and positive drug controlled clinical trial, subjects were enrolled and randomly divided into 3groups. The patients were treated with high dose(400 or 800mg/d) and low dose(300 or600mg/d) of Morinda officinalis oligose capsule or fluxetine hydrochloride tablets(20 or30mg/d) for six weeks.Results:The effective rates were 70.34%(control group), 66.38%(high dose group) and68.91%(low dose group), no siginificant difference can we found among 3 groups(P>0.05).To evaluate the primary efficacy, we stratified by center CMHχ2 test. The result show that the difference among three groups was no significant(P> 0.05). Non-inferiority test is qualified among high dose and low dose of Morinda officinalis oligose capsule and fluxetine hydrochloride tablets. The incidences of adverse events were 29.41%(high dose group), 19.83%(low dose group)and 24.17%(controlled group), respectively, there was no significance difference.Conclusion:Morinda officinalis oligose capsule is not inferior to the fluoxetine tablets in the treatment of mild and moderate depression(kidney deficiency syndrome). The drug is safe in the therapeutic dose, and adverse reaction are mild. It is suitable for the mild and moderate depression.