vascular dementia
Conditions
Interventions
test group:Jianpi Yishen Huazhuo granules
control groups:Jianpi Yishen Huazhuo granules placebo
Sponsors
Xiyuan Hospital, China Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the Western medical diagnostic criteria for vascular dementia. (2) Meet the Chinese medicine diagnostic criteria for vascular dementia. (3) Hachinski ischemia scale score = 7. (4) Clinical Dementia Rating Scale (CDR) dementia degree rating of mild and moderate dementia (CDR=1.0, 2.0). (5) 14 = MMSE score = 26. (6) Age 45-80 years old, gender is not limited. (7) Those who can cooperate in completing the test. (8) Voluntary subjects and their legal guardians sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who have been definitively diagnosed or suspected of having a combination of other types of dementia through existing history, scales, and imaging tests, such as Alzheimer's disease, dementia with Lewy bodies, frontotemporal lobe dementia, Parkinson's disease, mixed-type dementia, demyelinating diseases of the central nervous system, tumors, hydrocephalus, traumatic injuries, and infections of the central system; (2) Those who cannot complete the examination with severe neurological deficits, such as hemiplegia, various kinds of aphasia, and audio-visual disorders; (3) Abnormal laboratory parameters: Hb (hemoglobin) and Plt (platelet count) less than the lower limit; APTT (activated partial thromboplastin time) exceeding the normal value for more than 10 seconds, PT (plasminogen time) exceeding the normal value for more than 3 seconds; Cr (creatinine) exceeding 1.5 times the upper limit; ALT (alanine aminotransferase), AST (aspartate aminotransferase) or ALP (alkaline phosphate), Y-GL (alkaline phosphatase), and Y-phosphate. ALT (alanine aminotransferase), AST (aspartate aminotransferase) or ALP (alkaline phosphate), Y-GT (Y-glutamyltransferase) more than 2 times the upper limit of normal, and TBiL (total bilirubin) more than 1.5 times the upper limit of normal; (4) Severe mental illness (e.g., depression, schizophrenia) and epilepsy; (5) Alcohol and drug abusers; (6) The subject is allergic or hypersensitive to the test drug; (7) The following drugs are being used and cannot be stopped, such as Donepezil, Carboplatin, Staphylococcus aureus, Memantine, Nimodipine, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VaDAS-Cog ;Chinese Medicine Symptom Score; | — |
Countries
China
Contacts
Public ContactZhang Yunling
Xiyuan Hospital, China Academy of Traditional Chinese Medicine
Outcome results
None listed