Ischemic stroke
Conditions
Interventions
treatment group:Naoshuantong Capsules (0.4 g/capsule, 3 capsules each time, 3 times daily, orally, for 90 consecutive days) plus basic treatment.
control group:Naoshuantong Capsule placebo (0.4 g/capsule, 3 capsules each time, 3 times daily, orally, for 90 consecutive days) plus basic treatment.
Sponsors
The First Affiliated Hospital of Henan University of CM
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Meets the diagnosis of acute ischemic stroke; 2.ESRS score is >= 3 and NIHSS score is = 2 elements; 4.Age is between 18 and under 80 years old; 5.Can be treated with the study drug within 72 hours of symptoms onset; 6.Informed consent signed.
Exclusion criteria
Exclusion criteria: 1. Received intravenous thrombolysis or endovascular treatment; 2.History of stroke with residual sequelae that significantly affect the outcome assessment, i.e., a modified Rankin Scale (mRS) score of >= 2 points before the onset of this stroke; 3.Suspected or known allergy to the ingredients of NC (Pu Huang, Chi Shao, Yu Jin, Tian Ma, Lou Lu), or individuals with allergic constitution; 4.Concurrent diseases affecting limb activity function, such as claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc., which cause limb activity dysfunction affecting neurological examination before treatment; 5.Inability to understand and/or comply with the study procedures and/or follow-up due to mental illness, cognitive or emotional disorders; 6.History of chronic or severe diseases in the digestive, respiratory, urinary, hematopoietic, reproductive, or other systems, which the investigator deems unsuitable for participation; 7.Liver dysfunction (ALT, AST values > 2 times the upper limit of normal) or renal insufficiency (serum creatinine > 1.5 times the upper limit of normal); 8.Participation in other clinical trials within the past 30 days; 9.Pregnant women, women planning to become pregnant, or nursing mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New stroke events (ischemic stroke and hemorrhagic stroke) within 90 days of onset; | — |
Secondary
| Measure | Time frame |
|---|---|
| New ischemic stroke events within 90 days of onset;New vascular events (ischemic stroke/hemorrhagic stroke/myocardium) within 90 days of onset Infarction/vascular death);The proportion of patients with good functional outcome (mRS <= 1 point) within 90 days after onset;Changes of EQ-5D-5L scale score compared with baseline at 90 days after onset; | — |
Countries
China
Contacts
Public ContactZhao Min
The First Affiliated Hospital of Henan University of CM
Outcome results
None listed