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A Clinical Study on the Treatment of Cerebral Small Vasscular Cognitive Impairment with a Chinese Herbal Formula Based on "Kidney Deficiency-Phlegm and Blood Stagnation" Theory

A Clinical Study on the Treatment of Cognitive Dysfunction caused by Cerebral Small Vessel Disease with a Traditional Chinese herbal formula Based on the "Kidney Deficiency-Phlegm and Blood Stasis" Theory

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000614
Enrollment
Unknown
Registered
2026-03-19
Start date
2024-06-15
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Cognitive Dysfunction caused by Cerebral Small Vessel Disease

Interventions

Experimental group:Naokang II granule

Sponsors

Xuanwu Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Meeting the diagnostic criteria for CSVCI in both Traditional Chinese Medicine and Western Medicine; 2) Aged between 40 and 80 years; 3) Able to cooperate in completing neuropsychological tests; 4) Voluntarily participating in the trial and signing an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients already diagnosed with dementia; 2) Cognitive impairment caused by other diseases such as hypothyroidism, mental disorders, or traumatic brain injury; 3) History of other neurological diseases such as epilepsy or intracranial space-occupying lesions; 4) Allergy or contraindication to the drugs used in the study; 5) Comorbid organ dysfunction, such as liver cirrhosis or renal failure; 6) Comorbid severe infectious diseases; 7) History of drug dependence or alcoholism; 8) Inability to cooperate with cognitive function assessments; 9) Use of any cognitive-enhancing drugs within 30 days prior to the study, including vitamin supplements (e.g., vitamin E), multivitamins, donepezil hydrochloride, galantamine, rivastigmine, memantine hydrochloride, or any other recently approved drug therapies.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment (MoCA) scores;

Secondary

MeasureTime frame
Traditional Chinese Medicine syndrome scores;Mini-Mental State Examination (MMSE) scores;Activities of Daily Living (ADL) scale scores;total Cerebral Small Vessel Disease (CSVD) burden scores ;

Countries

China

Contacts

Public ContactFeixue Wang

Xuanwu Hospital Capital Medical University

drwangfeixue@163.com13466363112

Outcome results

None listed

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