Evidence-based Evaluation of TCM Key Syndrome Differentiation and Treatment for Acute Ischemic Stroke

Inclusion Criteria:

• Acute disabling ischemic stroke (4≤ NIHSS score ≤25 at the time of randomization) thatcan be treated with study drug within 72 hours of symptoms onset. Acute ischemicstroke, were confirmed by magnetic resonance imaging (MRI) or computer tomography (CT).

• Adult subjects (male or female ≥ 40 years and ≤ 80 years)

• Diagnosis of phlegm-dampness syndrome with manifestation of heat (the score of "Phlegm-dampness syndrome" ≥10 with the score of "Internal fire syndrome" ≥2 inDiagnostic Scale for Syndrome Elements of Ischemic Stroke.

• Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

• Planned or already receiving intravenous thrombolysis or endovascular treatment (intravascular mechanical thrombectomy, intra-arterial thrombolysis and angioplasty).

• Patients who have received other traditional Chinese Medicine Decoctions (Granules)and Chinese patent medicines Treatment for stroke.

• Confirmed secondary stroke caused by tumors, brain trauma, hematological diseases,infectious diseases, hereditary diseases, rheumatic immune diseases, etc

• modified Rankin Scale (mRS) Score > 2 at randomization (pre-morbid historicalassessment).

• Other conditions that lead to motor dysfunction (i.n., severe osteoarthritis,rheumatoid arthritis, gouty arthritis, etc).

• Significant renal or hepatic insufficiency (defined as a serum creatinineconcentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST)value that is twice the upper limit of normal)

• Severe non-cardiovascular comorbidity with life expectancy < 3 months.

• Complicated with other diseases that limited the evaluation of neurological functionor affect the follow-up of patients.

• Known to be pregnant or breastfeeding.

• Currently receiving an investigational drug.