cerebral infarction
Conditions
Interventions
Controlled group:routine treatment+Fuyuan Xingnao Decoction formula granule placebo, which contained 5% of the active ingredients of the decoction
Treatment Group:routine treatment+Fuyuan Xingnao Decoction formula granule
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1)Meets the diagnostic criteria for stroke recovery in Western medicine;(2)Meets the diagnostic criteria for meridians in traditional Chinese medicine for stroke;(3)Meets the diagnostic criteria for wind phlegm stasis syndrome in traditional Chinese medicine(4)Disease duration of 7-45 days from the onset date;(5)Aged 18 years or older regardless of gender;(6)Ischemic stroke with a National Institutes of Health Stroke Scale (NIHSS) score of 4-20 (inclusive);(7)No significant functional impairment prior to the current episode (mRS score 0-1);(8)mRS score =2 at the time of enrollment;(9)Voluntary participation with signed informed consent form.
Exclusion criteria
Exclusion criteria: (1)Coagulation disorders hemorrhagic disorders or a history of severe bleeding within the past 3 months.(2)Cerebral embolism confirmed by examination to be due to brain tumors trauma parasitic infections metabolic disorders rheumatic heart disease or coronary heart disease.(3)Patients who have undergone thrombolytic therapy or vascular interventional treatment after the onset of the current episode.(4)Oral anticoagulant use (except enteric-coated aspirin tablets or clopidogrel bisulfate tablets).(5)Concurrent diseases affecting limb motor function that may interfere with neurological or functional assessments.(6)Severe cardiopulmonary diseases and chronic liver/kidney dysfunction defined as:1)Liver function: ALT/AST > 1.5 times the upper limit of normal;2)Renal function: BUN > 1.2 times the upper limit of normal or Cr > upper limit of normal.(7)Pregnant or breastfeeding women.(8)Legally defined disabled individuals.(9)Drug or alcohol abusers.(10) Known allergy or hypersensitivity to any component of the study drug.(11)Participation in another clinical trial within the past 3 months.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine (TCM) Syndrome Efficacy;Major Adverse Cardiovascular and Cerebrovascular Events;Stroke-Related Complications;National Institutes of Health Stroke Scale; | — |
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale (mRS) Score;Barthel Index (BI); | — |
Countries
China
Contacts
Public ContactLing Li
Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine
Outcome results
None listed