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Evaluation of the clinical efficacy and mechanism of action of Ginseng and Ma Yizhi Formula in vascular cognitive impairment based on objective index correlation studies

Evaluation of the clinical efficacy and mechanism of action of Ginseng and Ma Yizhi Formula in vascular cognitive impairment based on objective index correlation studies

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000733
Enrollment
Unknown
Registered
2024-11-25
Start date
2023-08-25
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Vascular Cognitive Impairment

Interventions

control subjects:Donepezil hydrochloride, 1 tablet, 2 times a day
Chinese medicine group:Ginseng and Ma Yi Zhi Granules, 1 sachet at a time, 2 times a day, to be taken

Sponsors

Xiyuan Hospital, China Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) 50 years old = age = 85 years old male or female, and confirmed by others (4) Meet the diagnostic criteria of Vascular Cognitive Impairment (VC-IND or VD (3) 11 scores = Brief Mental State Examination (MMSE) = 26 scores, and also satisfy the diagnostic criteria of Hachinski Ischemic Scale (HIS) > 7 scores) (5) Identify the diagnostic criteria of Chinese medicine for the syndrome of hyperactivity of liver and yang with deficiency of qi, blood stasis and blood stasis (6) Meet the requirements of this study. (7) have sufficient visual and auditory discrimination to undergo neuropsychological testing (8) have a certain level of education and have been able to read simple articles and write simple sentences (9) have a stable caregiver (10) have given informed consent and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) People with other causes of dementia, including Alzheimer's disease, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, epilepsy, chronic subdural hematoma, and multiple sclerosis, a history of severe head trauma with persistent neurological deficits, or a known structural abnormality of the brain (2) Thyroid disorders, vitamin B12 or folic acid deficiencies, severe anemia or malnutrition, severe cardiac, hepatic, pulmonary, or renal diseases, and other organ disorders affecting central nervous system functioning (3) Allergies (4) Concurrent use of cholinergic or anticholinergic medications and medications that have an effect on cognitive function (5) Depression, schizophrenia, and other psychiatric disorders (6) Alcoholism, long-term use of antipsychotic medications, and a history of severe head trauma (7) Failure to cooperate with the cognitive function test.

Design outcomes

Primary

MeasureTime frame
homocysteine (Cys);MMSE;Clinical Dementia Rating Scale;Ability to Perform Daily Living Skills Rating Scale;Alzheimer's Disease Rating Scale-Cognitive Items;5-Methyltetrahydrofolate homocysteine methyltransferase;Methylenetetrazolium folate reductase;Cystathionine beta-synthase;

Secondary

MeasureTime frame
TCM Symptom Integral Scale;

Countries

China

Contacts

Public ContactLiu Meixia

Xiyuan Hospital, China Academy of Traditional Chinese Medicine

liumeixia2004@126.com18701522362

Outcome results

None listed

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