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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)

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)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046995
Enrollment
Unknown
Registered
2021-06-06
Start date
2021-05-31
Completion date
Unknown
Last updated
2022-01-18

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

Conditions

vascular cognitive impairment non-dementia

Interventions

Sponsors

Department of Neurology, Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Alzheimer disease assessment scale-cognitive;

Secondary

MeasureTime frame
clinican's interview based impression of change-plus caregiver input;Montreal cognition assessment;Activity of daily life;

Countries

China

Contacts

Public ContactChen Haibo

Department of Neurology, Beijing Hospital

Chenhbneuro@263.net+86 13910622285

Outcome results

None listed

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