ITMCTR2100004911招募中1 期
A multicenter, randomized, double-blind placebo-controlled, pretrial clinical study for the effect of Yang-Xue Qing-Nao pill in the treatment of vascular cognitive impairment non-dementia (VCIND)
Department of Neurology, Beijing Hospital0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 45 至 85（—）
- 性别
- All
入选标准
- •1. Meet the diagnostic criteria for non-dementia vascular cognitive dysfunction;
- •2. Ability to read and write in Chinese, aged 45 to 85 years; have a consistent caregiver who can accompany 4 days in a week;
- •3. All patients underwent head MRI + hippocampal MRI scan, which met the entry criteria and were reviewed by the central imaging;
- •4. Hachiski Ischemia Scale> 4 points;
- •5. The patient agrees to participate in the trial and signs an informed consent form.
- •6. MRI entry criteria are as follows:
- •(1) At least one of the following conditions exists:
- •1) Multiple (>=3) small infarcts (3-20mm in diameter) in the supratentorial cortex, with or without any degree of white matter damage (WML);
- •2) Moderate to severe WML (Fazekas rating >= 2) with or without small infarction;
- •3) There is one or more small infarcts in key areas such as caudate nucleus, globus pallidus, and thalamus;
- •4) Small infarcts in the cortex and watershed areas;
- •(2) There is no hemorrhage, hydrocephalus, white matter damage of special causes (such as multiple sclerosis) and localized cortical atrophy;
- •(3) There is no atrophy of hippocampus and entorhinal cortex.
排除标准
- •1. Hamilton Depression Scale > 12 points;
- •2. Genetic or inflammatory small vessel disease;
- •3. Known clinically significant liver diseases that may prevent the patient from completing the test, and/or total bilirubin, aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase are higher than 1.5 times the upper limit of normal;
- •4. Renal diseases that are known to have clinical significance that may prevent the patient from completing the test, and/or blood creatinine is higher than the laboratory normal range, and/or blood urea nitrogen is 1.5 times higher than the normal range;
- •5. A history of acute cerebrovascular disease within 3 months;
- •6. Currently active epilepsy;
- •7. Have a history of mental illness;
- •8. Peptic ulcer, gastrointestinal bleeding; hypothyroidism;
- •9. If you have taken any test drug within 28 days before the medication, the investigator believes that it may cause cognitive changes and damage to important organs;
- •10. Take drugs that may damage memory or treat MCI and dementia 2 weeks before the screening period (such as tranquilizers, anxiolytics, sleeping pills, nootropics, cholinergic drugs);
- •11. Accompanied by unstable blood system and immune system and other diseases, which are not in clinical remission;
- •12. Those who are known to have malignant tumors or intracranial tumors;
- •13. Those who have undergone surgery within three months, or have a history of trauma;
- •14. There are advanced, severe or unstable other diseases that affect the evaluation of its efficacy and safety;
- •15. Circumstances that the researcher considers inappropriate for inclusion in the study.
研究者
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