Acute Cerebral Infarction
Conditions
Interventions
Sponsors
The Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Inclusion criteria for patients with cerebral infarction] 1. Meet the diagnostic criteria of western medicine for acute cerebral infarction; 2. Comply with the diagnostic criteria of the Chinese meridian (blood stasis syndrome) in the acute phase of ischemic stroke in traditional Chinese medicine; 3. The onset time is less than 14 days; 4. 3 <= NIHSS < 15 points; 5. Aged 45 to 65 years; 6. The patient voluntarily signed an informed consent form. [Inclusion criteria for healthy volunteers] 1. Sign the informed consent form before the test, and have a full understanding of the test content, process and possible risks; Able to complete the research in accordance with the requirements of the test plan; 2. Male and female subjects aged 45 to 65 years (including 45 and 65 years old); 3. The weight of male subjects is not less than 50kg, and the weight of female subjects is not less than 45kg. Body mass index (BMI) = weight (kg)/height 2 (m2), the body mass index is within the range of 18-28kg/m2 (including the critical value); 4. Health status: clinically significant medical history such as heartlessness, liver, kidney, digestive tract, nervous system, respiratory system, mental abnormalities and metabolic abnormalities; 5. Physical examination and normal or abnormal vital signs have no clinical significance.
Exclusion criteria
Exclusion criteria: [Exclusion criteria for patients with cerebral infarction] 1. A comatose patient; 2. Those who need or have undergone thrombolysis or endovascular treatment; 3. Patients with allergies; 4. Patients whose blood pressure is still less than 90/60mmHg or >= 220mmHg/120mmHg after treatment; 5. Complicated with severe liver and kidney damage, and whose ALT, AST, Cr, and BUN levels are 1.5 times higher than normal; 6. Accompanied by other complications and complications that affect drug evaluation, such as severe cardiac insufficiency, severe mental illness, depression and dementia after stroke, cerebral hemorrhage after cerebral infarction, etc.; 7. Has had a stroke in the past; 8. Disabled patients (blindness, deafness, dumbness, intellectual disability, mental disability, etc.) stipulated by law, and physical disability caused by other diseases affect the assessors of neurological impairment; 9. Those with bleeding tendency or severe bleeding within 3 months; 10. Suspected or true history of alcohol or drug abuse, or other circumstances that reduce the possibility of enrollment or complicate enrollment based on the judgment of the investigator; 11. Menstrual period women, pregnant women and lactating women, those who have a positive pregnancy test or have recent birth plans; 12. Participating in other clinical trials or participating in other drug clinical trials within 3 months. [Exclusion criteria for healthy volunteers] 1. Donate blood or lose a lot of blood (>450mL) within three months before screening; 2. There have been major changes in diet or exercise habits recently; 3. Female subjects are breastfeeding during the screening period or during the test, or the result of serum pregnancy is positive; 4. Those who have a history of drug abuse or have used drugs in the past five years; 5. Other factors lead the researcher to believe that he cannot enter the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolomics differential metabolites;Transcriptomics differential genes; | — |
Countries
China
Contacts
Public ContactZhao Dexi
Changchun University of Chinese Medicine
Outcome results
None listed