摘要
Objective To evaluate the efficacy and safety of Tonifying Kidney-Yang Decoction(TKYD)in treating patients with vascular cognitive impairment(VCI)characterized by Shen(Kidney)-yang deficiency(SYD)syndrome.Methods This multicenter,double-blind,randomized,and placebo-controlled clinical trial was conducted in 4 hospitals of China from September 2020 to December 2021.Eligible patients were enrolled and randomly assigned in a 1:1 ratio to receive either TKYD granules or placebo twice daily for 12 weeks.The primary outcomes were changes in scores of the Beijing Version of the Montreal Cognitive Assessment(MoCA-BJ)and Shen-Yang Deficiency Syndrome Scale(SYDSS)from baseline to week 12.The secondary outcomes included scores of the Mini-Mental State Examination(MMSE),Color Trails Test interference index,Stroop Color and Word Test-Stroop interference effect,Neuropsychiatric Inventory(NPI),Apathy Evaluation Scale-Clinician Version,and Activities of Daily Living scales.Safety was monitored throughout the trial.Results A total of 120 patients completed the trial,including 63 and 57 in the TKYD and placebo groups,respectively.After 12 weeks of treatment,the TKYD group exhibited a significantly greater increase in MoCA-BJ(change:1.40 vs.0.11)and reduction in SYDSS scores(change:−12.17 vs.-7.46)than the placebo group(P<0.05 or P<0.01).Regarding specific domains of MoCA-BJ,TKYD exhibited significantly greater improvements in visuospatial/executive function,orientation and delayed recall(P<0.05 or P<0.01).In terms of change scores in SYDSS,TKYD also showed greater reductions in diarrhea before dawn,lumbago,and weakness of knees(P<0.05 or P<0.01).For the secondary outcomes,the TKYD group exhibited significantly higher MMSE scores and lower NPI scores compared with the placebo group(P<0.05 or P<0.01).No treatment-related adverse events were reported.Conclusion TKYD is effective and safe for improving cognitive function and alleviating SYD symptoms in VCI patients with SYD syndrome.(Registration No.ChiCTR1900025713).
基金
Supported by the National High Level Chinese Medicine Hospital Clinical Research Funding(Nos.DFRCZY-2024GJRC014 and 2025XZYJ03)
National Key Research and Development Program of China(No.2018YFC1704303)
the Graduate Independent Research Project of Beijing University of Chinese Medicine(No.ZJKT2025024)
the Scientific Research Projects of Xiyuan Hospital,China Academy of Chinese Medical Sciences(Nos.XYZX0405-30 and XYZX0204-05)。
