Th Tl Xb Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients

Launched by YAN ZHU · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a Chinese herbal medicine combined with standard medical treatment on patients who have experienced a cerebral infarction, commonly known as a stroke. The goal is to see if this combination can help improve recovery, particularly in areas like movement, speech, and thinking abilities. The trial will include 160 participants who are between the ages of 35 and 80 and have had their stroke diagnosed through imaging tests within the past 35 days. Participants will be randomly assigned to receive either the herbal treatment along with basic care or just the standard care alone.

If you or a loved one participates in this trial, you can expect to receive treatment for three months, followed by a three-month follow-up to assess recovery. The researchers will look at various outcomes, such as the degree of recovery and any disabilities that may arise. It's important to note that certain conditions, like severe heart or kidney problems, or those currently participating in other trials, would prevent someone from joining this study. Overall, this trial aims to explore new treatment options that might enhance recovery after a stroke by focusing on both traditional and modern medicine.

Gender

ALL

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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