Clinical trial NCT06549582: Th Tl Xb Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients
Official title: Effect of Taohong Tongluo Xiaoban Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients：a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Infarction
Chinese Herbal Medicine
Clinical Trial
Lipid Metabolism Disorder
Endothelial Injury
Lead sponsor: Beijing Electric Power Hospital
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 160
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 medicines combined basic medicine treatment, or to receive standard basic medicine treatment within 3 months after inclusion. Follow-up will be performed after the treatment for 3 months to evaluate the incidence and disability rates of limb impairment, language impairment, cognitive impairment, and emotional disorders. The primary outcome is modified Rankin Scale Score, which is measured by the overall distribution from 0 (no symptoms) to 6 (death). The secondary outcome include the Evaluation of Neurological Function Deficit score (National Institute of Health stroke scale scoring) and carotid atherosclerotic plaque score (Crouse scoring system for neck carotid atherosclerotic plaque scoring). Additional outcomes include laboratory indicator to analysis the reprogramming of lipid metabolism and endothelial Injury, Chinese medicine symptom and sign scoring system and biological indicators. The investigators will perform the intention-to-treat analysis for withdrawal and missing data, and estimate the health economic value.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. The National Institutes of Health Stroke Scale (NIHSS) evaluates a range of scores from 4 to 24.
3. 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.
4. Age range: ≥35 years to ≤80 years.
5. 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.
6. Patient informed consent must be obtained.
7. 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 Criteria:

1. 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);
2. onset occurring within a range of 30 to 40 days；
3. 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.
4. 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.
5. Individuals currently participating in other clinical trials are not eligible for inclusion.
6. Exclusion criteria include patients with mental illness, multiple body ulcers or joint contractures.
7. Non-compliance with treatment by patients and their families is considered an exclusion criterion.
8. Inability to comprehend the content of informed consent and inability to provide a signature on the informed consent form are also grounds for exclusion.
9. . Pregnant and lactating women are excluded from participation.

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Primary outcomes:
measure: Modified Rankin Scale Score
timeFrame: 0,30days,60days and 90days post-intervention
Secondary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 0,30days,60days and 90days post-intervention
measure: Carotid atherosclerotic plaque score
timeFrame: 0 and 90days post-intervention
Other outcomes:
measure: Laboratory indicator
timeFrame: 0 and 90days post-intervention
measure: Score of symptoms and signs in traditional Chinese medicine
timeFrame: 0,30days,60days and 90days post-intervention
measure: biological indicator
timeFrame: 0,30days,60days and 90days post-intervention
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