Acute ischemic stroke
Conditions
Interventions
Tiaoqi Tongmai Decoction Group:Tiaoqi Tongmai Decoction+rt-PA
Control Group:rt-PA
Sponsors
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 82 Years
Inclusion criteria
Inclusion criteria: (1) Meets Western medical diagnostic criteria for acute cerebral infarction;refer to the 2018 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.Key diagnostic features for acute ischemic stroke (acute cerebral infarction) include: acute onset;focal neurological deficits (e.g., weakness or numbness on one side of the face or limb,speech impairment),with some cases presenting global neurological deficits; symptoms or signs may persist for any duration (when imaging demonstrates an ischemic lesion) or for at least 24 hours (when no imaging evidence of a lesion is present); exclusion of non-vascular causes; exclusion of intracerebral hemorrhage via brain CT/MRI. (2) Age = 18 years; (3) Time from symptom onset to hospital admission = 4.5 hours; (4) 3 = NIHSS = 8; (5) Patient is conscious with no history of neurological dysfunction; (6) Meets thrombolysis criteria and undergoes thrombolytic therapy; (7) Good compliance to complete the entire trial; (8) Informed consent obtained and signed; (9) Meets the diagnostic criteria for "Qi Mechanism Reversal and Phlegm-Heat with Intestinal Obstruction Syndrome." The TCM diagnostic standards for stroke under this syndrome refer to Lu Shangling's Academic Thought and Clinical Experience in Stroke Transmission and the Diagnosis and Efficacy Evaluation Standards for Stroke (Trial). Refer to the Stroke Syndrome Quantification Score for syndrome scoring. Primary Symptoms: Sudden onset, hemiplegia, limb numbness,facial deviation,slurred speech, diminished or absent sensation, limb rigidity, or altered consciousness. Secondary Symptoms: Facial flushing with heat, coarse breathing with foul breath, restlessness, abdominal distension with constipation, severe cases presenting urinary or fecal retention, abundant yellow phlegm. Tongue and Pulse Manifestations: Reddish-purple tongue body, thick yellow or brownish-dry greasy coating, taut and slippery pulse. Diagnosis is established when presenting with at least two primary symptoms and two secondary symptoms, combined with onset pattern, precipitating factors, prodromal signs, and age. When these criteria are not met, imaging studies may confirm diagnosis.
Exclusion criteria
Exclusion criteria: (1) Individuals with severe head trauma or cerebral infarction within the past 3 months; (2) Suspected subarachnoid hemorrhage or epileptic seizures; (3) Arterial puncture at sites difficult to compress for hemostasis within the past 7 days; (4) History of intracranial hemorrhage; (5) Presence of intracranial tumors, arteriovenous malformations, or aneurysms; (6) Recent major surgical procedures; (7) Hypertension with systolic blood pressure =180 mmHg or diastolic blood pressure =100 mmHg; (8) Recent severe internal bleeding or acute bleeding tendency with platelet count below 100 × 10000000000/L; (9) Current use of thrombin inhibitors or oral anticoagulants (e.g., warfarin), heparin therapy within 48 hours, or abnormal laboratory tests (APTT, INR, platelet count, ECT, TT, or Xa activity); (10) Blood glucose 22.22 mmol/L. (11) CT or MRI indicating extensive cerebral infarction (infarct area >1/3 of the middle cerebral artery territory); (12) Patients with bacterial endocarditis or acute pancreatitis; (13) Severe bulbar palsy or other causes of dysphagia preventing oral administration of Chinese herbal medicine; (14) Aortic arch dissection; (15) Stroke affecting central visceral organs; (16) Allergy to herbal medicine components or alteplase; (17) Patients undergoing endovascular intervention; (18) Pre-onset mRS =2 , or pre-existing conditions causing disability (e.g., traumatic disability, rheumatic osteoarthritis); (19) Cardioembolic stroke.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| National Institutes of Health Stroke Scale(NIHSS);Barthel Index;Traditional Chinese Medicine Syndrome Observation Form;Stroke recurrence rate;Mortality; | — |
Countries
China
Contacts
Public ContactXu Xiangqing
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Outcome results
None listed