Acute Ischemic Stroke
Conditions
Interventions
Experimental group:Basic treatment (anti-platelet anti-coagulation anti-fiber etc.)+ intervention based on guidelines: 4 Yinaokang capsules 3 times a day orally for 10-14 days
Control group:Guideline-based therapy (antiplatelet, anticoagulation, antifibrotic, etc.)
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Fulfilling the diagnosis of acute ischaemic stroke and all confirmed by MRI; (2) Onset within 72 hours; (3) 18 years old = 80 years old; (4) 4 points = NIHSS score = 22 points; (5) The diagnosis of phlegm-dampness syndrome is established (the score of phlegm-dampness syndrome in the Diagnostic Scale of Ischemic Stroke Symptoms and Symptoms is =10); (6) The diagnosis of blood stasis syndrome is established (blood stasis syndrome in the Diagnostic Scale of Ischemic Stroke Symptoms and Criteria Elements =10); (7) The patient or legal representative gave informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) The cause of morbidity was cardiogenic embolism; (2) Patients who have received or intend to receive intravenous thrombolysis or endovascular intervention (including endovascular mechanical thrombolysis arterial thrombolysis angioplasty) or those who are expected to receive endovascular or surgical treatment within the next 3 months; 3) Patients who have been treated with other Chinese herbal medicinal soup (granules) and other proprietary Chinese medicines for the treatment of stroke after the current onset of the disease; (4) Patients with stroke caused by brain tumour traumatic brain injury blood disease infectious disease hereditary disease rheumatic immune disease etc. confirmed by examination; (5) Patients with a history of stroke with sequelae affecting outcome assessment i.e. mRS score =2 before the onset of the current stroke; (6) Patients with combined claudication osteoarthritis rheumatoid arthritis gouty arthritis etc. which cause limb movement dysfunction and affect the neurological function test; (7) Combined serious liver and renal insufficiency (Remarks: liver insufficiency means that the ALT or AST value is greater than 2 times the upper limit of normal; renal insufficiency means that the blood creatinine value is greater than 2 times the upper limit of normal); (8) Those who suffer from other serious life-threatening diseases with an expected survival time of less than 3 months; (9) Combination of other diseases that limit the evaluation of neurological function or affect the follow-up of patients; 10) Women who are pregnant planning to become pregnant or breastfeeding; 11) Those currently participating in other interventional clinical trials. 12) Severe impairment of consciousness: NIHSS score 1a > 1; dysphagia inability to take capsules orally; any of the NIHSS scores 5a 5b 6a 6b > 2; 13) Presence of coagulation disorders systemic bleeding leukopenia (< 2 × 10 9/L) or thrombocytopenia (< 100 × 10 9/L); 14) Known history of allergy including allergy to Yibin Kang capsule; 15) Active peptic ulcer; 16) History of gastrointestinal bleeding within 3 months prior to randomisation grouping or major surgery within 30 days prior to randomisation grouping.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients treated for 90 (±7) days (mRS 0-1); | — |
Secondary
| Measure | Time frame |
|---|---|
| MoCA scores at 14 (±2) days and 90 (±7) days of treatment;Incidence of ischaemic cerebrovascular disease (symptomatic ischaemic stroke) during the follow-up period;Incidence of combined cardiovascular and cerebrovascular events during the follow-up period;(2)7(±1)14(±2)NIHSS = 1NIHSS=4;Changes in TCM evidence on days 7(±1), 14(±2) and 90(±7) of treatment;Treatment 90 (±7) days SS-QoL Stroke Specific Survival Scale;Improvement in ability to perform activities of daily living at 90 (±7) days of treatment (proportion of patients with Barthel Index =85);The multi-omics changes at 7 days of Yinao Kang treatment; | — |
Countries
China
Contacts
Public ContactYefeng Cai
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed