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Objective <p>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.</p> Methods <p>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.</p> Results <p>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 <i>vs.</i> 0.11) and reduction in SYDSS scores (change: −12.17 <i>vs.</i> −7.46) than the placebo group (<i>P</i>&lt;0.05 or <i>P</i>&lt;0.01). Regarding specific domains of MoCA-BJ, TKYD exhibited significantly greater improvements in visuospatial/executive function, orientation and delayed recall (<i>P</i>&lt;0.05 or <i>P</i>&lt;0.01). In terms of change scores in SYDSS, TKYD also showed greater reductions in diarrhea before dawn, lumbago, and weakness of knees (<i>P</i>&lt;0.05 or <i>P</i>&lt;0.01). For the secondary outcomes, the TKYD group exhibited significantly higher MMSE scores and lower NPI scores compared with the placebo group (<i>P</i>&lt;0.05 or <i>P</i>&lt;0.01). No treatment-related adverse events were reported.</p> Conclusion <p>TKYD is effective and safe for improving cognitive function and alleviating SYD symptoms in VCI patients with SYD syndrome. (Registration No. ChiCTR1900025713)</p>

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Efficacy and Safety of Tonifying Kidney-Yang Decoction for Vascular Cognitive Impairment: A Multicenter Double-Blind Randomized Controlled Trial

  • 期刊论文

  • 发表日期：

    2026年2月28日

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  • Chun-yan Guo,
  • Zhen-min Xu,
  • Min Wang,
  • Chen Fu,
  • Xiang-lan Jin,
  • Ying Zhang,
  • Tao Li,
  • Huan-min Niu,
  • Yun-ling Zhang,
  • Bao-xin Chen

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)