Ischemic Stroke, Acute
Conditions
Keywords
Post-acute Ischemic Stroke, Ischemic Stroke, Acute Ischemic Stroke
Brief summary
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.
Interventions
DRUGGetong Tongluo Capsule
Oral 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.
OTHERMatched Starch Placebo Capsule
Starch-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.
DRUGStandard Routine Therapy for Ischemic Stroke
Individualized 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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign the informed consent form 2. Aged between 18 and 80 years old 3. Conform to the diagnosis of acute ischemic stroke referring to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023) 4. Hospital admission within 21 days after disease onset
Exclusion criteria
1. 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). 2. 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). 3. 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. 4. 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. 5. Patients who received any preparations containing the same active ingredients as the study drug (e.g., Pueraria lobata) within 2 weeks prior to stroke onset. 6. Patients with a history of allergy to the study drug or preparations with identical active ingredients. 7. Patients who received antibiotics within 1 month before onset; those taking probiotics or prebiotics long-term; patients with a past or in-hospital confirmed gastrointestinal disease history. 8. Pregnant and lactating women. 9. Patients deemed unsuitable for participation in this trial at the investigator's discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of modified Rankin Scale (mRS) scores | Baseline, 3-month follow-up and 6-month follow-up | Scores range from 0 (no symptoms) to 6 (death); higher scores indicate poorer functional recovery |
| Incidence of adverse events | Through study completion, an average of 6 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Athens Insomnia Scale (AIS) score | Baseline, 3-month follow-up and 6-month follow-up | Total score ranges from 0 to 24; higher scores indicate more severe insomnia (worse sleep condition) |
| Proportion of Traditional Chinese Medicine(TCM) Syndrome Improvement | Baseline, 3-month follow-up and 6-month follow-up | 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 | Baseline, 3-month follow-up and 6-month follow-up | Total score ranges from 0 to 100; higher scores indicate superior independent daily function |
| Hamilton Depression Rating Scale (HAMD) score | Baseline, 3-month follow-up and 6-month follow-up | Total score ranges from 0 to 52; higher scores indicate more severe depressive symptoms |
| Hamilton Anxiety Rating Scale (HAMA) score | Baseline, 3-month follow-up and 6-month follow-up | Total score ranges from 0 to 56; higher scores indicate more severe anxiety symptoms |
| Montreal Cognitive Assessment (MoCA) score | Baseline, 3-month follow-up and 6-month follow-up | Total score ranges from 0 to 30; higher scores indicate better cognitive function. |
| MMSE score | Baseline, 3-month follow-up and 6-month follow-up | Total score ranges from 0 to 30; higher scores indicate better cognitive performance |
| Incidence rate of drug-related adverse reactions | Through study completion, an average of 6 months | — |
Outcome results
None listed