ITMCTR2100005177
Not yet recruiting
未知
Study on the influence of the key gene phenotype and the effect of qi-supplementing and blood-activating therapy on the therapeutic effect of statins in vascular dementia
Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine0 sitesTBD
ConditionsVascular Dementia
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Vascular Dementia
- Sponsor
- Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria for subjects with vascular dementia:
- •1\. Aged 40 to 80 years, gender is not limited;
- •2\. More than 6 years of education (including 6 years);
- •3\. Meet the diagnostic criteria for vascular dementia, and the course of dementia lasts for more than 6 months;
- •4\. Patients with mild or moderate disease, with a score between 10 and 24 on the Mini\-Mental State Examination (MMSE);
- •5\. Patients who meet the indications for statin use and are currently taking statin therapy or have not taken statin;
- •6\. Modified Hachinski Ischemia Scale (mHIS) total score \>\= 4; Hamilton Depression Scale (HAMD) total score \<\= 17;
- •7\. TCM syndrome differentiation is Qi deficiency and blood stasis syndrome, and the syndrome score is \>\=7 points;
- •8\. The subjects voluntarily participate in the clinical trial, and they and their agents sign the informed consent form before the trial.
- •Inclusion criteria for healthy subjects:
Exclusion Criteria
- •Vascular dementia subjects:
- •1\. Dementia caused by brain diseases other than vascular dementia, such as Parkinson's disease, central nervous system demyelinating disease, tumor, hydrocephalus, trauma, central system infection such as syphilis, AIDS, Creutzfeldt\-Jakob disease, etc.;
- •2\. Those with severe neurological deficits who cannot complete the examination, such as audio\-visual impairment;
- •3\. Severe circulatory, respiratory, urinary and hematopoietic diseases, such as uncontrolled asthma, etc.;
- •4\. Serious mental illness, such as schizophrenia and epilepsy;
- •5\. Alcohol and drug abuse;
- •6\. Those who are allergic to the drug ingredients used in the research;
- •7\. Participated in other clinical trials within 3 months before the start of this study.
- •Healthy subjects:
- •1\. Abnormal laboratory indicators: Hb and Plt are less than the lower limit of normal; APTT exceeds the normal control value for more than 10 seconds, PT exceeds the normal control value for more than 3 seconds; Scr exceeds the upper limit of the normal value; ALT, AST, ALP, ?\-GT, TBIL 1\.5 times the upper limit of normal;
Outcomes
Primary Outcomes
Not specified
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