Acute ischemic stroke
Conditions
Interventions
control group:Modern medical guidelines for standardized treatment
treatment group:Oral traditional Chinese medicine + acupuncture + Chinese medicine enema
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 and =80, male or female; (2) After the onset of the disease, 4=NIHSS=25; The sum of NIHSS fifth and sixth scores =2. (3) Onset within 72 hours (including 72 hours); (4) Patients who met the diagnostic criteria of ischemic stroke in Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018 and had good recovery after the first attack or the last attack (mRS score =1 point before the attack); (5) Meet the diagnostic criteria of ischemic stroke in TCM (6)Obtain informed consent signed voluntarily by patients or their legal representatives and approved by the ETHICS Committee.
Exclusion criteria
Exclusion criteria: (1) CT or MRI showed intracranial hemorrhage, epidural hematoma and subdural hematoma; (2) CT or MRI indicated large scale cerebral infarction (ASPECT score 1/3 of the blood supply area of MCA or infarction volume > 70ml); (3) Patients with intracranial hemorrhage after vascularization treatment (such as thrombolysis, thrombectomy, ultra-early thrombus aspiration and stenting); (4) Patients with hemorrhagic diseases or bleeding tendency; (5) Refractory hypertension beyond drug control was defined as systolic blood pressure > 185mmHg or diastolic blood pressure > 110mmHg; (6) Liver function during screening: ALT or AST > 2.0 times the upper limit of normal value; Renal function: serum creatinine (Scr) > 1.5 times the upper limit of normal; Blood glucose 25; (9) life expectancy < 90 days or unable to complete 90±14 days follow-up; (10) patients with mental diseases; (11) pregnant or lactating women; (12) allergic to the test drug ingredients; (13) Participants in clinical trials of other drugs or devices who have not completed the primary study endpoint; (14) Other conditions that the investigator judged inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| BI score;UA;IL-6;NIHSS score;GCS score;Evaluation index of TCM syndrome and symptom efficacy;Blood coagulation function;Hcy;Cys C;CPR;TNF-a; | — |
Countries
China
Contacts
Public ContactFu Zheng
Outcome results
None listed