Acute ischemic stroke
Conditions
Interventions
Test group:Tiandan Tongluo tablets, 5 tablets/time, 3 times/day
by mouth. Xiaoshuan Tongluo tablet simulation tablet, 6 tablets/time, 3 times/day
by mouth.
Placebo group:Tiandan Tongluo tablet simulation tablet, 5 tablets/time, 3 times/day
By mouth. Xiaoshuan Tongluo tablet simulation tablet, 6 tablets/time, 3 times/day
By mouth.
Positive drug group:Xiaoshuantongluo tablet, 6 tablets/time, 3 times/day
By mouth. Tiandan Tongluo tablet simulation tablet, 5 tablets/time, 3 times/day
Sponsors
Dongzhimen Hospital of Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. In line with Western diagnostic criteria for acute ischemic stroke; 3. TCM syndrome differentiation is meridians and collaterals of stroke, wind phlegm and blood stasis and obstruction of veins; 4. Patients with first onset or good recovery after last onset (modified Rankin scale score 0-1); 5. Patients with duration <= 7 days <= 30 days; 6. National Institutes of Health Stroke Scale (NIHSS) score 4-22; 7. Voluntary informed consent.
Exclusion criteria
Exclusion criteria: 1. Brain imaging examination confirmed brain tumor, encephalitis, brain abscess and other diseases causing similar symptoms, or confirmed hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage and so on; 2. Patients with hemorrhagic disease or bleeding tendency, or patients with lower limb venous thrombosis; 3. Patients who have received or plan to receive vasodilatory treatment after onset, such as thrombolysis, thrombectomy, ultra-early thrombectomy, and stenting; 4. Patients who could not stop concomitant therapy prohibited by this protocol before the day before randomization were enrolled; 5. Patients with severe abnormal liver and kidney function (AST >= 2 times the upper limit of normal value or ALT >= 2 times the upper limit of normal value, Cr > the upper limit of normal value); 6. Other serious organ or systemic diseases accompanied by malignancy of any organ or system; 7. Pregnant or lactating women or those who have recently planned to have children; 8. Suspected or confirmed history of alcohol or drug abuse, or other conditions that, in the investigator's judgment, would reduce or complicate enrollment; 9. Known or suspected allergic to the tested drug or allergic constitution; 10. Participants who have participated in other clinical trials within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in NIHSS score from baseline ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of mRS Score = 75 and >= 95 and the change of score from baseline;Change value of NIHSS score, proportion of NIHSS score = 4 points, and change value of NIHSS score from baseline;The change value of TCM syndrome efficacy, total score and individual score compared with baseline ;Change from baseline in post-stroke symptom grading scores ;The changes in the severity of each symptom and the disappearance rate of each symptom in the stroke syndrome factor evaluation scale were compared with the baseline at 14, 30, 60 and 90 days after treatment;The changes of DHI scores compared with baseline;Proportion of patients with new cerebrovascular events at 14, 30, 60, and 90 days after treatment;Change in MoCA score from baseline ;Changes in EQ-5D scores from baseline; | — |
Countries
China
Contacts
Public ContactGao Ying, Zhou Li
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed