A randomised,double-blind,placebo/fluoxetine hydrochloride-controlled,multicentre phase Ⅲ clinical trial of shenyu ningshen tablets(ningyu yixing tablets)for the treatment of mild to moderate depression
ZHAO Yang
ZENG Mei-hua
YANG Qiao-ning
GAO Hong-yang
LI Tao
GAO Rui
Abstract：Objective:This study aimed to assess the clinical efficacy and safety of Shenyu Ningshen Tablets(NYYX)in the treatment of mild-to-moderate depression.Methods:In this multicenter,randomized,double-blind trial,572 eligible participants(CCMD-3-diagnosed,baseline HAMD-17:14～24)were allocated to three arms:NYYX(2.4 g thrice daily,n=344),fluoxetine(10 mg·d-1 first week,20 mg·d-1 subsequent weeks,n=115),and placebo(n=113)for 8 weeks.The primary endpoint compared adjusted mean differences in HAMD-17 score changes from baseline using modified intention-to-treat analysis,with non-inferiority margin prespecified as Δ=2.5 against fluoxetine and superiority testing versus placebo.Results:After 8 weeks of treatment,the NYYX group demonstrated a mean reduction in HAMD-17 score of 10.50±4.46 points,which was significantly greater than that of the placebo group(7.03±5.07,P<0.05)and achieved non-inferiority to fluoxetine(10.13±3.94;adjusted difference:-0.25,97.5%CI:-1.18 to 0.68).Safety assessments revealed no treatment-related adverse events in the NYYX group(0%),in contrast to 8.8%incidence in fluoxetine recipients(P<0.01).Conclusion:NYYX exhibits non-inferior antidepressant efficacy to fluoxetine with enhanced tolerability,positioning it as a viable botanical alternative for mild-to-moderate depression.These findings advance evidence-based integration of traditional Chinese medicine into mainstream psychiatric therapeutics.
Keywords：Chinese patent medicineShenyu Ningshen TabletsNingyu Yixing Tabletsdepressionclinical trial
Publication Date：2026-02-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 318-324 )