Real-World Efficacy and Safety of Zishenyizhi Pill for Cognitive Impairment Associated With Cerebral Small Vessel Disease: Protocol for a Multicenter Prospective Observational Study.

ABSTRACT:

Background

Cerebral small vessel disease (CSVD) is a leading cause of vascular cognitive impairment, contributing to 36% to 67% of vascular dementia cases. Current therapies, primarily cholinesterase inhibitors, offer limited efficacy and significant adverse effects. Traditional Chinese medicine, particularly the zishenyizhi pill, which is a multiherb formulation targeting yin deficiency and blood stasis, has shown promise in preliminary studies but lacks robust clinical validation.

Objective

We designed this study to evaluate the real-world efficacy and safety of zishenyizhi pill combined with conventional Western therapy for CSVD-related cognitive impairment.

Methods

This multicenter, prospective, nonrandomized controlled trial enrolled 246 patients from 4 instituti

SUBMITTER: Sun X 

PROVIDER: S-EPMC12723357 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature