The purpose of this single-center, randomized, double-blind, controlled trial is to clarify the clinical efficacy and safety of Getong Tongluo Capsule in patients with ischemic stroke. Combined with gut microbiome and metabolomics techniques, investigators will explore whether this medicine exerts neuroprotective effects via the gut-brain axis. Investigators will further verify its pharmacological mechanism through animal experiments to provide evidence for its clinical application.
Voluntarily sign the informed consent form
Aged between 18 and 80 years old
Conform to the diagnosis of acute ischemic stroke referring to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023)
Hospital admission within 21 days after disease onset
Patients with mild or no neurological deficits on admission: those with a score of 0 on the Modified Rankin Scale (mRS) at admission (defined as completely asymptomatic).
Patients with severe baseline disability: those with a pre-stroke mRS score ≥ 3 (indicating moderate to severe disability requiring partial or full assistance with activities of daily living).
Patients with transient ischemic attack, concomitant cerebral hemorrhage or subarachnoid hemorrhage; those complicated with brain tumor, Alzheimer's disease, psychiatric disorders, or suspected pre-stroke cognitive dysfunction.
Patients complicated with severe cardiac diseases including valvular heart disease, infective endocarditis, myocardial infarction and heart failure; severe hepatic or renal insufficiency, respiratory failure, malignant tumors, or massive gastrointestinal hemorrhage.
Parallel
Getong Tongluo Capsule
DrugOral proprietary Chinese medicine for convalescent ischemic stroke. Subjects take 2 capsules (0.25 g each), twice daily, on top of guideline-standardized antiplatelet, lipid-lowering, antihypertensive and hypoglycemic routine stroke treatment. Treatment period ranges from 14±7 days to 6 months after stroke onset.
Matched Starch Placebo Capsule
Other interventionStarch-filled blank capsules identical to Getong Tongluo Capsule in appearance, size and taste. Subjects take 2 capsules (0.25 g each), twice daily together with standardized basic stroke therapy, for 14±7 days to 6 months post stroke.
Standard Routine Therapy for Ischemic Stroke
DrugIndividualized guideline-directed basic stroke care including antiplatelet, lipid-regulating, blood pressure and glucose lowering medications, provided to all participants in both treatment and placebo arms throughout the study.
Distribution of modified Rankin Scale (mRS) scores
Scores range from 0 (no symptoms) to 6 (death); higher scores indicate poorer functional recovery
Incidence of adverse events
Athens Insomnia Scale (AIS) score
Total score ranges from 0 to 24; higher scores indicate more severe insomnia (worse sleep condition)
Proportion of Traditional Chinese Medicine(TCM) Syndrome Improvement
The scale evaluates six TCM syndrome elements (endogenous wind, internal fire, blood stasis, phlegm-dampness, qi deficiency, yin deficiency) with weighted symptom scores for each element. Higher subscores for each syndrome element represent more severe relevant syndrome manifestations.
Activities of Daily Living (ADL) score
Total score ranges from 0 to 100; higher scores indicate superior independent daily function
Hamilton Depression Rating Scale (HAMD) score
Total score ranges from 0 to 52; higher scores indicate more severe depressive symptoms
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