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)
- Conditions
- vascular cognitive impairment non-dementia
- Registration Number
- ITMCTR2100004911
- Lead Sponsor
- Department of Neurology, Beijing Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Alzheimer disease assessment scale-cognitive;
- Secondary Outcome Measures
Name Time Method Activity of daily life;Montreal cognition assessment;clinican's interview based impression of change-plus caregiver input;