Ischemic stroke
Conditions
Interventions
Experimental Group:Conventional stroke treatment combined with Dan Deng Tong Nao Dropping Pills, one bag each time, three times a day, for 90 consecutive days
Control group:Conventional stroke treatment + Dan Deng Tong Nao Drop Pills placebo, one bag each time, three times a day, for 90 consecutive days
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old to <=80 years old, gender not limited; 2. National Stroke Institute Scale score after the onset of the disease: 6=NIHSS=20; 3. Within 7 days of symptom onset; 4. Patients diagnosed with ischemic stroke according to the "Key Points for the Diagnosis of Various Major Cerebrovascular Diseases in China 2019", with a good prognosis after the first or last attack (MRS Score =1 before the current attack); 5. The informed consent form approved by the ethics committee is voluntarily signed by the patient or their legal representative.
Exclusion criteria
Exclusion criteria: 1. Head CT or MRI confirmed intracranial hemorrhagic diseases: cerebral hemorrhage, epidural hematoma, subdural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, traumatic cerebral hemorrhage, etc. Or those who have undergone post-infarction hemorrhage transformation in this cerebral infarction; If it is only bleeding, the suitability for enrollment can be determined by the researcher. 2. Patients with cerebral infarction accompanied by consciousness disorder (NIHSS score Ia item >1 point), posterior circulation infarction or transient ischemic attack (TIA); 3. Patients suffering from severe mental disorders, depression, or comorbidities that affect cognitive function, such as Alzheimer's disease, Parkinson's dementia, or Lewy body dementia, who are unable or unwilling to cooperate with the research; 4. After the onset of this disease, it is planned to undergo intravenous thrombolysis or thrombectomy or other surgical treatments. 5. Those who have allergic reactions or allergic constitutions to any research drugs or other components; 6. Suffering from severe liver and kidney diseases or having abnormal kidney and liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST]>=3.0× upper limit of normal value [ULN]; Patients with serum creatinine [Cr]>2.0×ULN; 7. Stroke patients confirmed by examination to be caused by brain tumors, brain trauma, blood diseases, etc. 8. There are indications for anticoagulation (suspected cardiac embolism, such as atrial fibrillation, artificial heart valves, suspected endocarditis); 9. A history of intracranial hemorrhage or cerebral amyloid angiopathy; 10. A history of aneurysms (including intracranial aneurysms and peripheral aneurysms); 11. Confirmed or suspected acute coronary syndrome; 12. High-risk bradyarrhythmias such as sick sinus syndrome with second or third degree atrioventricular block, and bradycarry-related syncope induced without a pacemaker implanted; 13. A history of gastrointestinal bleeding within 3 months before randomization, or having undergone major surgery within 30 days before randomization; 14. Patients with severe hypertension (systolic blood pressure =220mmHg or diastolic blood pressure >=120mmHg) before the first administration that has not been controlled after treatment; 15. Those with a history of stroke and severe remaining symptoms that affect the evaluation of therapeutic effects; 16. Female patients who are pregnant, breastfeeding or have plans to become pregnant in the near future, as well as those who are unwilling to use contraceptive measures; 17. Patients who have participated in other clinical trials or are currently participating in other clinical studies within the three months prior to this study; 18.Patients whom researchers consider unsuitable to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with functional independence (modified Rankin Scale (mRS) =2); | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with recurrent stroke (ischemic stroke and cerebral hemorrhage);;The proportion of patients with functional independence (mRS=2);;The proportion of patients with no disability or minimal disability (mRS=1);;Changes in the National Institutes of Health Stroke Scale (NIHSS) score;;The proportion of composite cerebrovascular events (ischemic stroke, cerebral hemorrhage, myocardial infarction and vascular death);;Changes in the Barthel Index score;;Changes in the Self-Rating Depression Scale (SDS) score;;The changes in TCM syndrome scores;; | — |
Countries
China
Contacts
Public ContactQing Ye
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed