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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050004
Enrollment
Unknown
Registered
2021-08-15
Start date
2021-08-17
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Vascular Dementia

Interventions

Sponsors

Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 80 Years

Inclusion 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 =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: 1. Aged 25 to 80 years, no gender limitation; 2. No previous or current history of severe cardiovascular and cerebrovascular diseases, stroke and other neurological diseases; 3. No obvious cognitive impairment, depression, anxiety, etc., and no serious mental system diseases; 4. Have not taken any drugs in the past 3 months, and laboratory test indicators such as blood lipids, liver and kidney function, and coagulation function are normal/abnormal but have no clinical significance; 5. Those who volunteered to participate in clinical trials and signed the informed consent.

Exclusion criteria

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; 2. Severe circulatory, respiratory, urinary, digestive, hematopoietic system diseases (such as unstable angina, uncontrolled asthma, active gastric bleeding, etc.) and cancer; 3. Serious mental illness, such as schizophrenia and epilepsy; 4. Alcohol and drug abuse; 5. Participated in other clinical trials within 3 months before the start of this study.

Design outcomes

Primary

MeasureTime frame
Blood lipid level;Mini-mental State Examination (MMSE);

Secondary

MeasureTime frame
Syndrome score of traditional Chinese medicine;Blood concentration of statins and metabolites/n;Analysis of endogenous metabolites;The ApoE gene test;

Countries

China

Contacts

Public ContactGuo Chunli

Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine

1156097595@qq.com+86 15010318837

Outcome results

None listed

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