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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Getong Tongluo Capsule | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of modified Rankin Scale (mRS) scores | Scores range from 0 (no symptoms) to 6 (death); higher scores indicate poorer functional recovery | Baseline, 3-month follow-up and 6-month follow-up |
| Incidence of adverse events | Through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Athens Insomnia Scale (AIS) score | Total score ranges from 0 to 24; higher scores indicate more severe insomnia (worse sleep condition) | Baseline, 3-month follow-up and 6-month follow-up |
| Proportion of Traditional Chinese Medicine(TCM) Syndrome Improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Matched Starch Placebo Capsule | Other | 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. |
|
| Standard Routine Therapy for Ischemic Stroke | Drug | 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. |
|
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. |
| Baseline, 3-month follow-up and 6-month follow-up |
| Activities of Daily Living (ADL) score | Total score ranges from 0 to 100; higher scores indicate superior independent daily function | Baseline, 3-month follow-up and 6-month follow-up |
| Hamilton Depression Rating Scale (HAMD) score | Total score ranges from 0 to 52; higher scores indicate more severe depressive symptoms | Baseline, 3-month follow-up and 6-month follow-up |
| Hamilton Anxiety Rating Scale (HAMA) score | Total score ranges from 0 to 56; higher scores indicate more severe anxiety symptoms | Baseline, 3-month follow-up and 6-month follow-up |
| Montreal Cognitive Assessment (MoCA) score | Total score ranges from 0 to 30; higher scores indicate better cognitive function. | Baseline, 3-month follow-up and 6-month follow-up |
| MMSE score | Total score ranges from 0 to 30; higher scores indicate better cognitive performance | Baseline, 3-month follow-up and 6-month follow-up |
| Incidence rate of drug-related adverse reactions | Through study completion, an average of 6 months |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |