Ischemic stroke
Conditions
Interventions
2:Xuesaitong Capsules Combined plus Aspirin
Sponsors
Henan Provincial Hospital of Traditional Chinese Medicine (the Second Affiliated Hospital of Henan University of Chinese Medicine)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the trial, Patients or their legal representatives will be able to sign the informed consent voluntarily. 2. Aged 18-80 years, gender is not limited 3.Meet the diagnostic criteria for ischemic stroke through CT and other imaging examination results; 4. Patients with TOAST classification are patients with large artery atherosclerotic stroke; 5. Meet the TCM syndrome differentiation standard of apoplexy involving meridians & collaterals with syndrome of blood stasis; 6. The course of disease is 3~14 days, and oral drug therapy can be performed at the discretion of the investigator; 7. Patients with first onset or previous stroke without obvious sequelae (mRS Score =1); 8.When enrolled mRS grade> 2,neurological impairment degree score 6 =NIHSS =15
Exclusion criteria
Exclusion criteria: 1.Lack of clear imaging diagnostic evidence, such as CT and MRI, or insufficient imaging diagnostic evidence to clarify the diagnosis. 2.Cardiac embolization, arteriole occlusion, other definite causes and unknown causes in the TOAST type. 3.Progressive stroke, severe stenosis and occlusion of intracranial and carotid large vessels, cerebral hemorrhage after cerebral infarction, transient ischemic attack, posterior circulation infarction and cerebral arteritis. 4.Brain embolism caused by brain tumor, brain trauma, brain parasitic disease, rheumatic heart disease, coronary heart disease and other heart diseases combined with atrial fibrillation. 5.Patients who were unable to complete daily activities independently due to various diseases and physical weakness before the disease had serious impact on the efficacy evaluation; 6.Patients who are already using or during the trial must use aspirin and clopidogrel; 7. Patients have any type of major surgery before 30 days of randomization, or plan to have any angioplasty or vascular surgery within 6 months after randomization; 8.Patients who have been treated with intravenous thrombolysis, arterial thrombectomy, ultra-early thrombus aspiration and stenting. 9.Patients with other diseases affecting limb movement and function, patients with limb movement dysfunction caused by claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis before treatment, which may affect neurological function examination; 10.Patients with severe hypertension or diabetes mellitus who still cannot be controlled after treatment. 11.Patients with severe cardiac disease (e. g. acute myocardial infarction or malignant arrhythmia or congestive cardiac failure with NYHA cardiac function grade-). 12.Patients with severeliver and kidney damage, or abnormal liver and renal function tests ( ALT and AST levels were 2 times higher than the normal value,SCr was 1.5 times higher than the normal value) 13.Patients with severe cardiovascular, respiratory, digestive, urinary, hematopoietic and metabolic system diseases 14.Patients with severe depression and dementia after stroke 15.Patients with bleeding tendency such as peptic ulcer, or severe bleeding within 3 months 16.Patients with contraindications to aspirin, including gout, bronchial asthma, nasal polyp syndrome, hepatic and renal dysfunction, cardiac insufficiency, and coagulation dysfunction. 17.Patients can't understand or subject to the research program and follow-up because of mental disorders (eg., schizophrenia, bidirectional mental disorders, suicidal tendencies or suicidal history), cognitive impairment or emotional problems. 18.Patients who drink alcohol or have acute alcoholism and suffer to drug abuse or drug dependence. 19.Patients who are allergic to the ingredients of the study drug (including Sanchi-tongshu capsule, Xuesaitong capsule, aspirin).. 20.Patients who cannot tolerate the long-term administration of aspirin enteric-coated tablets. 21.Pregnant or lactating women, and who plan to be pregnant recently 22.Patients who have participated in other interventional clinical trials within 3 months prior to the first dose. 23.Researchers believe that there are some circumstances that are inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with mRS=2;Change from baseline in S-Cole score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with mRS=2;The proportion of subjects whose mRS dropped by 2 levels compared with the baseline;The proportion of subjects whose mRS decreased by 1 level compared with the baseline;Proportion of subjects with NIHSS=1;The proportion of subjects whose NIHSS decreased by 5 points compared with the baseline;Proportion of participants with a 50% reduction from baseline in NIHSS;The magnitude of the decrease from baseline in NIHSS;Proportion of participants with a Barthel index BI = 75;Proportion of subjects with a Barthel index BI of = 95;The remarkable and effective rate of therapeutic effect on traditional Chinese medicine syndromes;Disappearance rate of individual TCM symptoms; | — |
Countries
China
Contacts
Public ContactGuan Dongsheng
Henan Provincial Hospital of Traditional Chinese Medicine 17/5000 Chengdu Huashen Technology Group Co., Ltd. pharmaceutical factory
Outcome results
None listed