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Real-World Study of Zishen Yizhi Pill in Treating Cognitive Impairment Associated with Cerebral Small Vessel Disease (Yin Deficiency and Blood Stasis Syndrome)

Real-World Study of Zishen Yizhi Pill in Treating Cognitive Impairment Associated with Cerebral Small Vessel Disease (Yin Deficiency and Blood Stasis Syndrome)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000553
Enrollment
Unknown
Registered
2025-03-20
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cognitive impairment of cerebral small vessel disease

Interventions

Control group:Guideline-based standardized internal medicine treatment
Treatment Group :Zishen Yizhi Wan

Sponsors

Hunan Provincia Hospital of Integrated Traditional Chinese and Western Medicine ( The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Age = 60 years; (2) Presence of cognitive impairment due to cerebral small vessel disease; (3) Meeting the diagnostic criteria for Yin Deficiency and Blood Stasis Syndrome according to Traditional Chinese Medicine (TCM) standards; (4) Voluntary participation in the trial and signing of the informed consent form by the patient or their legal representative.

Exclusion criteria

Exclusion criteria: (1) Presence of other neurological diseases leading to cognitive impairment such as Alzheimer's disease frontotemporal dementia Lewy body dementia Parkinson's disease multiple sclerosis traumatic brain injury autoimmune diseases or genetic disorders; (2) Presence of impaired consciousness unstable vital signs (e.g. blood pressure respiration heart rate) or severe cardiopulmonary diseases as determined by the investigator to be unsuitable for participation in this study; (3) Inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders emotional disturbances or severe visual/auditory impairments; (4) Presence of severe liver kidney digestive system or hematopoietic system diseases.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment;

Secondary

MeasureTime frame
Minimum Mental State Examination;Traditional Chinese Medicine Syndrome Score;Hopkins Verbal Learning Test;Hospital anxiety and depression scale;Vascular dementia assessment scale-cog;trail making test;Clock Drawing Test;neuropsychiatric inventory;Boston naming test-2;EuroQol Five Dimensions Questionnaire;Instrumental Activity of Daily Living;

Countries

China

Contacts

Public ContactWu dahua

Hunan Provincia Hospital of Integrated Traditional Chinese and Western Medicine ( The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)

893049352@qq.com13508491768

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026