Vascular dementia
Conditions
Interventions
control group:The control group will receive mimetic granule of Shenmayizhi formula consists of 95% dextrin and 5% ginseng formula granule(1 bag twice daily),and taken with warm boiled water.
treatment group:The treatment group was given ginseng hemp nootropic formula granules 1 bag each time 2 times a day and taken with warm boiled water.
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Clinical diagnosis of Mild to moderate vascular dementia according to the NINDS-AIREN of 2011 and meets the diagnostic criteria for deficiency stasis and hyperimpotence syndrome in traditional chinese medicne. 2.Patients 55= aged =85 male or female 3.CDR score of 1 to 2. At least one CDR of 1.0 or higher or an overall CDR score of 1.0 in the three instrumental categories of daily living (personal care family and hobbies community affairs). 4.MMSE score of 10 to 26 5.HIS score=7 6.MRI or CT shows cerebrovascular lesions; 7.Subject is able to complete neuropsychological testing; 8.Subject has a stable caregiver; 9.Subjects voluntarily and their legal guardian agree to participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Brain MRI (or CT) scan showed clinically significant cortical hemosiderosis intracranial tumor and changes suggestive of normal intracranial pressure hydrocephalus; 2.Dementia caused by other diseases(eg Alzheimer's disease Parkinson's disease Lewy body disease any type of frontotemporal dementia Huntington's disease amyotrophic lateral sclerosis multiple sclerosis systemic lupus erythematosus progressive supranuclear palsy neurosyphilis HIV learning disability intellectual disability hypoxic brain injury and major head trauma with loss of consciousness leading to persistent cognitive impairment); 3.Presence of evidence of clinically significant or unstable psychiatric illness including schizophrenia or other psychiatric disorder or bipolar disorder based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria. Subjects with a history of major depressive disorder as judged by the investigator (if there has been no episode in the 24 months prior to the screening date and they are considered to be in remission or their depression has been controlled by treatment they can be included in the trial); 4.Those who have a combination of serious circulatory respiratory and digestive disorders 5.Patients with severe abnormal liver and kidney function 6.Those who have taken drugs other than the study drug that affect cognitive function within 1 month. 7.Those with allergic constitution or known allergy to the components of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug Toxicology;Direct medical expenses;Technical suitability;Characteristics of traditional Chinese medicine;Pharmacological properties;Suitability for use;Safety metrics;Incremental cost-effectiveness ratio;Human safety;Industrial innovation;accessibility;Vascular Dementia Rating Scale;Clinical innovation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression to dementia (CDR global score = 1.0) at baseline (CDR global score = 1.0);TCM Syndrome Rating Scale;Mini-Mental State Examination Scale;Time to first stroke;Neuropsychiatric Scale (NPI) score;Number of treatment-emergent adverse events (AEs);Activities of Daily Living Scale;Change in hypersensitive C-reactive protein levels;Time to first major adverse cardiovascular event (MACE) (including non-fatal myocardial infarction non-fatal stroke and all-cause death);Clinical Dementia Rating Scale score;Time to disease stage progression (based on CDR overall score); | — |
Countries
China
Contacts
Public ContactPei Hui
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed