ArticleJMIR research protocols2025
Real-World Efficacy and Safety of Zishenyizhi Pill for Cognitive Impairment Associated With Cerebral Small Vessel Disease: Protocol for a Multicenter Prospective Observational Study.
Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundCerebral 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.
objectiveWe designed this study to evaluate the real-world efficacy and safety of zishenyizhi pill combined with conventional Western therapy for CSVD-related cognitive impairment.
methodsThis multicenter, prospective, nonrandomized controlled trial enrolled 246 patients from 4 institutions in Hunan province, China. Participants were stratified into 2 groups: the intervention group received zishenyizhi pill plus standard Western therapy, whereas the control group received conventional integrated Chinese-Western therapy. Cognitive outcomes (Montreal Cognitive Assessment, Mini-Mental State Examination, Vascular Dementia Assessment Scale cognitive subscale, and Trail Making Test parts A and B), traditional Chinese medicine syndrome scores, and safety parameters were assessed over 12 weeks.
resultsParticipant recruitment is scheduled to commence in April 2025, with an anticipated enrollment of 246 participants by December 2026. At present, patient recruitment is underway, and preliminary analysis of medical record data is being conducted. Final data collection is expected to conclude by April 2027, with results projected for publication in September 2027.
conclusionsThe anticipated findings suggest that zishenyizhi pill may improve multiple cognitive domains in patients with cognitive impairment associated with CSVD while demonstrating a favorable safety profile. If validated, zishenyizhi pill could serve as a safe and effective adjunctive therapy for CSVD-related cognitive dysfunction.
trial registrationInternational Traditional Medicine Clinical Trial Registry ITMCTR2025000553; https://itmctr.ccebtcm.org.cn/mgt/project/view/-4790836881284495026. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/77661.
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