The objective of this observational study is to understand the long-term effects of traditional Chinese medicine (TCM) intervention on patients with cerebral infarction onset within \<48 hours and comorbid diabetes. The primary question it aims to address is:
Can long-term TCM intervention for the treatment of ischemic cerebrovascular disease comorbid with diabetes improve patients' neurological deficits and self-care ability? Participants receiving TCM intervention (universal treatment combined with syndrome-specific treatment) as part of routine cerebrovascular disease management will undergo follow-up assessments at 30 days, 90 days, 6 months, and 12 months within 1 year to evaluate neurological status (e.g., mRS score, NIHSS score) and quality of life indicators.
Age ≥ 18 years old, regardless of gender.
Fasting blood glucose ≥ 7.0 mmol/L.
2-hour postprandial blood glucose ≥ 11.1 mmol/L.
Glycated hemoglobin ≥ 6.5%.
None
Parallel
(Intensive treatment) Chuanzhi Tongluo Capsules
Drug4 capsules each time, orally, 3 times a day; administration from day 1 to day 14 of the disease.
Standard Treatment (Guideline-Based)
Other interventionCombination therapy including: 1. Antiplatelet: aspirin 100 mg/day + clopidogrel 75 mg/day. 2. Lipid-lowering: atorvastatin 20 mg/day. 3. Antidiabetic: metformin 500 mg bid (max 2000 mg/day). \*Doses may be adjusted per local guidelines or patient tolerance.
(Sequential treatment) Chuanzhi Tongluo Capsules
Drug2 capsules each time, orally, 3 times a day; administration from day 15 to day 365.
TCM Syndrome Differentiation Decoction
DrugIndividualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.
Primary outcome indicator
The proportion of patients with mRS score 0-2 at 90 days
BARC Type III and V Major Bleeding (Incidence %)
The percentage of patients meeting the following criteria: Type IIIa is overt bleeding with a hemoglobin drop of 3-\<5 g/dL or requiring transfusion; Type IIIb is a hemoglobin drop of \>5 g/dL, cardiac tamponade, bleeding requiring surgical intervention (excluding dental/nasal/skin/hemorrhoidal bleeding), or requiring intravenous vasoactive drugs; Type IIIc is intracranial/spinal hemorrhage (excluding microhemorrhage/hemorrhagic transformation); Type V is fatal bleeding.
1-Year Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs) (Cumulative Incidence %)
The percentage of patients who experience major adverse cardiovascular and cerebrovascular events (in accordance with international criteria: including myocardial infarction, recurrent stroke, cardiovascular death, etc.) within 1 year.
1-Year All-Cause Mortality (Mortality Rate %)
The percentage of patients who die from any cause within 1 year after treatment.
Rate of Change in eGFR (mL/min/1.73 m²/year)
Estimated glomerular filtration rate (eGFR) calculated using CKD-EPI formula. Annualized rate of change derived from serial measurements at baseline, 6, and 12 months.
12-month Renal Composite Endpoint
Composite of: 1) Sustained ≥50% decline in eGFR from baseline; 2) Sustained eGFR \<15 mL/min/1.73 m²; 3) Initiation of long-term dialysis or renal transplantation.
Rate of Change in UACR (mg/g/year)
Urine albumin-to-creatinine ratio (UACR) measured from first-morning void samples. Annualized rate of change calculated from baseline, 6, and 12-month data.
Change in Tubular Markers (α1-MG, β2-MG, NAG) at 12 Months
Urinary biomarkers of tubular injury: α1-microglobulin (α1-MG), β2-microglobulin (β2-MG), and N-acetyl-β-D-glucosaminidase (NAG). Concentrations measured by immunoturbidimetry (α1-MG, β2-MG) and enzymatic assay (NAG).
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