Status:
NOT_YET_RECRUITING
Th Tl Xb Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients
Lead Sponsor:
Yan Zhu
Conditions:
Cerebral Infarction
Chinese Herbal Medicine
Eligibility:
All Genders
35-80 years
Phase:
NA
Brief Summary
This study is a prospective, open-label, randomized control trial. It is planning to include 160 cerebral infarction patients which will be randomized in a 1﹕1 fashion to receive Chinese herbal medici...
Eligibility Criteria
Inclusion
- The CT/MRI examination findings were consistent with the diagnosis of Western cerebral infarction, aligning with the TCM apoplexy diagnosis. Primary stroke occurred 35±5 days ago.
- The National Institutes of Health Stroke Scale (NIHSS) evaluates a range of scores from 4 to 24.
- Coronary atherosclerotic heart disease is confirmed through coronary CT angiography. Carotid artery ultrasonography is employed to ascertain the presence or absence of plaque formation, with stable plaques exhibiting predominantly high and uneven echogenicity, while unstable plaques displayed low echo or irregular hypoechoic regions.
- Age range: ≥35 years to ≤80 years.
- First onset requires; patients with previous diseases and no sequelae such as limb paralysis should not affect the NIHSS score, and the modified Rankin scale (mRS) score should be ≤1 point.
- Patient informed consent must be obtained.
- The criteria for the syndrome of phlegm and blood stasis are as follows: Main syndrome: hemiplegia, mouth and eyes skew, speech retarding or silent, sensation diminished or disappeared; Secondary syndrome: excessive sputum, fat tongue with teeth marks on the side, dark red tongue, sublingual vein blue or tortuous, tongue spots, white or thick greasy fur, pulse slippery.
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Exclusion
- subarachnoid hemorrhage, transient ischemic attack, or other intracranial lesions such as intracranial tumor, aneurysm, vascular malformation, cerebral cysticercosis, intracerebral schistosomiasis, encephalitis, meningitis, hydrocephalus, and sequelae of brain trauma; Nonatherosclerotic thrombotic cerebral infarction (e.g., cardiogenic embolism, hypercoagulability disorders, endovascular shedding and arteritis);
- onset occurring within a range of 30 to 40 days；
- The patient presents with limb motor dysfunction, emotional disorder, cognitive impairment, or speech impairment resulting from pre-existing conditions (e.g., surgery, trauma, or congenital disability) prior to the onset of cerebrovascular accident.
- Patients with severe cardiac disease, heart failure, liver or kidney failure, malignant tumors, gastrointestinal bleeding, severe infections, or uncontrolled diabetes are excluded from the study.
- Individuals currently participating in other clinical trials are not eligible for inclusion.
- Exclusion criteria include patients with mental illness, multiple body ulcers or joint contractures.
- Non-compliance with treatment by patients and their families is considered an exclusion criterion.
- Inability to comprehend the content of informed consent and inability to provide a signature on the informed consent form are also grounds for exclusion.
- . Pregnant and lactating women are excluded from participation.
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Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06549582
Start Date
October 1 2024
End Date
December 1 2026
Last Update
August 14 2024
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