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The aim of the study is to determine if LongShengZhi Capsule is effective and safe in patients with ischemic stroke in comparison to placebo. This trial is a prospective, multicenter, randomized, placebo-controlled, double-blinded, parallel-group, superiority trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LongShengZhi capsule | Experimental | Experimental group |
|
| LongShengZhi capsule placebo | Placebo Comparator | Placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LongShengZhi capsule | Drug | LongShengZhi capsules, orally, 5 capsules each time, three times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with excellent outcome | Excellent outcome defined as a modified Rankin scale (mRS) score ≤ 1 (scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death). | 90 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of the modified Rankin scale (mRS) scores | Modified Rankin scale (mRS) scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death. | 30 days after randomization |
| Distribution of the modified Rankin scale (mRS) scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dandan Zhang, PhD, MD | Contact | +8618810532113 | zx1zy@126.com |
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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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| ID | Term |
|---|---|
| C000724157 | LongShengZhi |
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| LongShengZhi capsule placebo | Drug | LongShengZhi capsules placebo, orally, 5 capsules each time, three times a day. |
|
Modified Rankin scale (mRS) scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death. |
| 90 days after randomization |
| The proportion of patients with good outcome | Good outcome defined as a modified Rankin scale (mRS) score ≤2(scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death). | 30 days after randomization |
| The proportion of patients with good outcome | Good outcome defined as a modified Rankin scale (mRS) score ≤2(scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death). | 90 days after randomization |
| Changes in National Institutes of Health Stroke Scale (NIHSS) scores | Difference of NIHSS scores (range =0-42, with higher scores indicating more severe strokes) between baseline and 30 days after randomization or 90 days after randomization. | 90 days after randomization |
| The proportion of patients with poor quality of life | Poor quality of life defined as EuroQol Five Dimensions Questionnaire (EQ-D5) index score ≤0.5. The EQ-5D index score is measured on a scale of 0 (death) to 1 (full health). | 30 days after randomization |
| The proportion of patients with poor quality of life | Poor quality of life defined as EuroQol Five Dimensions Questionnaire (EQ-D5) index score ≤0.5. The EQ-5D index score is measured on a scale of 0 (death) to 1 (full health). | 90 days after randomization |
| The proportion of patients with functional independence | Functional independence measured withe BI, which was a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best). | 30 days after randomization |
| The proportion of patients with functional independence | Functional independence measured withe BI, which was a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best). | 90 days after randomization |
| Changes in Motor function | Motor function, measured by the Fugl-Meyer Motor Scale (FMMS) score(range from 0-100, with lower score showing worse motor status) change from baseline to 90 days after randomization. | 90 days after randomization |
| Changes in Cognitive function | Cognitive function, as measured using the Montreal Cognitive Assessment (MoCA) score (range from 0 to 30, with less than 26 indicating cognitive impairment) change from baseline to 90 days after randomization. | 90 days after randomization |
| The proportion of adverse events (AEs) | The proportion of AEs during the treatment. | 90 days after randomization |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |