Transcriptomics and Metabolomics Research on Acute Cerebral Infarction (Blood Stasis Syndrome)

Phase 1

Recruiting

• Conditions: Acute Cerebral Infarction

• Registration Number: ITMCTR2100005406
• Lead Sponsor: The Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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 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.

Study & Design

• Study Type: Screening
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolomics differential metabolites;Transcriptomics differential genes;