Vascular dementia
Conditions
Interventions
Experimental Group:Lingzhi Yizhi Decoction Chinese Herbal Granules
Control group:Lingzhi Yizhi Decoction Placebo
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: According to the research criteria for VaD diagnosis based on AHA/ASA and VASCOG: (1) Meets the diagnostic criteria for dementia; (2) Evidence of cerebrovascular disease: medical history clinical manifestations MRI/CT showing multiple large vessel infarctions single strategic site infarctions (angular gyrus thalamus basal forebrain anterior or posterior cerebral artery supply areas) multiple basal ganglia infarctions white matter injury (extensive ischemia of white matter involving at least 25% of the entire white matter area of the brain); Excluding medial temporal lobe atrophy and other special images; (3) There is a correlation between dementia and cerebrovascular disease: cognitive impairment occurs within 3 months after a definite stroke; Or sudden cognitive decline fluctuating or progressive cognitive impairment; (4) Mini Mental State Examination (MMSE) score = 11 and = 26;; (5) Hachinski Ischemia Scale (HIS) score = 7 points; (6) Gender is not limited age = 50 years and = 80 years old; (7) Having sufficient vision and hearing to undergo neuropsychological testing; (8) Having a certain level of education able to read simple articles and write simple sentences in the past; (9) Having stable caregivers; (10) Informed consent shall be obtained and signed by the legal guardian.
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed with other causes of dementia such as mixed dementia Alzheimer's disease frontotemporal dementia Parkinson's disease dementia Lewy body dementia Huntington's disease normal pressure hydrocephalus etc; (2) Diseases that combine subdural hematoma communicating hydrocephalus brain tumors thyroid disease and vitamin deficiency leading to cognitive and functional impairments in the brain; (3) Patients with severe depression (HAMD = 17) and severe anxiety disorder (HAMA = 12); (4) Individuals with severe neurological deficits that prevent them from completing relevant examinations such as convenient hand hemiplegia various aphasia audio-visual disorders etc; (5) Poor control of cardiovascular disease such as patients with severe arrhythmia who have experienced myocardial infarction within the past 3 months before participating in the trial or those with heart function grades 3-4 and systolic blood pressure = 90mmHg or = 180mmHg; (6) Severe liver and kidney dysfunction such as ALT or AST levels exceeding 1.5 times the upper limit of normal or serum Cr levels exceeding 1.0 times the upper limit of normal; (7) Uncontrolled diabetes (HbA1c is more than 1.0 times the upper limit of normal value); (8) Patients with combined asthma chronic obstructive pulmonary disease polyneuropathy myasthenia gravis and muscle atrophy; (9) Patients with severe digestive disorders gastrointestinal obstruction gastric and duodenal ulcers and other gastrointestinal diseases that can affect drug absorption; (10) Individuals with a history of epilepsy glaucoma alcohol abuse or substance abuse; (11) Individuals who have taken acetylcholinesterase inhibitors memantine nifedipine and traditional Chinese medicine puzzle drugs within the past month; (12) Those who have taken sympathomimetic drugs or antihistamines within 48 hours prior to the evaluation which may affect their assessment scores; (13) Individuals with allergic constitution and allergies to the components of the experimental medication; (14) Those who are currently participating in other clinical trials or have completed clinical trials of other drugs within one month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vascular Dementia Assessment Scale - Cognitive Section (VADAS-cog);Clinical Dementia Rating - Sum of Boxes (CDR-SB); | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination (MMSE);Activities of Daily Living (ADL);Delayed Story Recall (DSR);Clock Drawing Test (CDT);Dementia Syndrome Elements Scale (PES-D-11);Homocysteine;Interleukin-12;Multimodal magnetic resonance imaging; | — |
Countries
China
Contacts
Public ContactLi Wen Tao
Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine
Outcome results
None listed