ITMCTR2100005406招募中1 期
Transcriptomics and Metabolomics Research on Acute Cerebral Infarction (Blood Stasis Syndrome)
The Affiliated Hospital of Changchun University of Traditional Chinese Medicine0 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
- Screening
入排标准
- 性别
- All
入选标准
- •[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.
排除标准
- •[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.
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