ITMCTR2100005177尚未招募未知
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 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 25 至 80（—）
- 性别
- All
入选标准
- •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:
- •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.
排除标准
- •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.
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