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

GUO Chun-yan; XU Zhen-min; WANG Min; FU Chen; JIN Xiang-lan; ZHANG Ying; LI Tao; NIU Huan-min; ZHANG Yun-ling; CHEN Bao-xin

doi:10.1007/s11655-026-3953-y

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

Original Articles | Updated：2026-03-25

- Efficacy and Safety of Tonifying Kidney-Yang Decoction for Vascular Cognitive Impairment: A Multicenter Double-Blind Randomized Controlled Trial
- Efficacy and Safety of Tonifying Kidney-Yang Decoction for Vascular Cognitive Impairment: A Multicenter Double-Blind Randomized Controlled Trial
- Chinese Journal of Integrative Medicine 2026年32卷第4期页码：291-298
- Affiliations：
  
  1.Graduate School, Beijing University of Chinese Medicine, Beijing (100029), China
  2.Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing (100091), China
  3.Department of Traditional Chinese Medicine, Honghui Hospital, Xi'an Jiao Tong University, Xi'an (710001), China
  4.Department of Neurology, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing (100078), China
  5.Department of Rehabilitation, Shanxi Provincial Hospital of Traditional Chinese Medicine, Taiyuan (030024), China
  6.Department of Neurology, Beijing First Hospital of Integrated Chinese and Western Medicine, Beijing (100026), China
- Author bio：
  
  Prof. ZHANG Yun-ling, E-mail: yunlingzhang2004@126.com
  Prof. CHEN Bao-xin, E-mail: chenbaoxin2008@163.com;
- Funds：
  
  the National High Level Chinese Medicine Hospital Clinical Research Funding(DFRCZY-2024GJRC014;2025XZYJ03);National Key Research and Development Program of China(2018YFC1704303);the Graduate Independent Research Project of Beijing University of Chinese Medicine(ZJKT2025024);the Scientific Research Projects of Xiyuan Hospital, China Academy of Chinese Medical Sciences(XYZX0405-30;XYZX0204-05)
- DOI：10.1007/s11655-026-3953-y
  中图分类号：
- 录用：2025-07-18，
  
  网络首发：2026-02-28，
  
  纸质出版：2026-04
- Accepted：
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GUO Chun-yan, XU Zhen-min, WANG Min, 等. Efficacy and Safety of Tonifying Kidney-Yang Decoction for Vascular Cognitive Impairment: A Multicenter Double-Blind Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2026,32(4):291-298.

GUO Chun-yan, XU Zhen-min, WANG Min, et al. Efficacy and Safety of Tonifying Kidney-Yang Decoction for Vascular Cognitive Impairment: A Multicenter Double-Blind Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2026, 32(4): 291-298.
GUO Chun-yan, XU Zhen-min, WANG Min, 等. Efficacy and Safety of Tonifying Kidney-Yang Decoction for Vascular Cognitive Impairment: A Multicenter Double-Blind Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2026,32(4):291-298. DOI： 10.1007/s11655-026-3953-y.

GUO Chun-yan, XU Zhen-min, WANG Min, et al. Efficacy and Safety of Tonifying Kidney-Yang Decoction for Vascular Cognitive Impairment: A Multicenter Double-Blind Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2026, 32(4): 291-298. DOI： 10.1007/s11655-026-3953-y.

摘要

Abstract

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 (chang

e: 1.40

. 0.11) and reduction in SYDSS scores (change: –12.17

. –7.46) than the placebo group (

0.05 or

0.01). Regarding specific domains of MoCA-BJ

TKYD exhibited significantly greater improvements in visuospatial/executive function

orientation and delayed recall (

0.05 or

0.01). In terms of change scores in SYDSS

TKYD also showed greater reductions in diarrhea before dawn

lumbago

and weakness of knees (

0.05 or

0.01). For the secondary outcomes

the TKYD group exhibited significantly higher MMSE scores and lower NPI scores compared with the placebo group (

0.05 or

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)

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