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According to the random number table, all patients were divided into short-term treatment group, long-term treatment group and non-intervention stroke control group according to the proportion of (1:1:1) epilepsy disease modifier idebenone. Patients in the short-term treatment group will take idebenone for a total course of 14 days (acute period) after stroke, and patients in the long-term treatment group will take idebenone for a total course of 3 months after stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Idebenone short-term treatment group | Experimental | The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase). |
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| Group B: Idebenone long-term treatment group | Experimental | The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| idebenone 30 mg for 14 days | Drug | The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with epilepsy after stroke | Count the number of people with post-stroke epilepsy | At the time of enrollment |
| The proportion of patients with epilepsy after stroke | Count the number of people with post-stroke epilepsy | 24 weeks after enrollment |
| The proportion of patients with epilepsy after stroke | Count the number of people with post-stroke epilepsy | 48 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| National Institutes of Health Stroke Scale (NIHSS) | The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients | At the time of enrollment |
| National Institutes of Health Stroke Scale (NIHSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Feng, PhD | Contact | 86-13873123853 | fenglihx@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410008 | China |
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| ID | Term |
|---|---|
| C036619 | idebenone |
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| idebenone 30 mg for 3 months | Drug | The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months. |
|
The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients |
| 24 weeks after enrollment |
| National Institutes of Health Stroke Scale (NIHSS) | The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients | 48 weeks after enrollment |
| Hamilton Anxiety Scale (HAMA) | The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety | At the time of enrollment |
| Hamilton Anxiety Scale (HAMA) | The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety | 24 weeks after enrollment |
| Hamilton Anxiety Scale (HAMA) | The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety | 48 weeks after enrollment |
| Hamilton Depression Scale (HAMD) | The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression | At the time of enrollment |
| Hamilton Depression Scale (HAMD) | The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression | 24 weeks after enrollment |
| Hamilton Depression Scale (HAMD) | The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression | 48 weeks after enrollment |
| Pittsburgh sleep quality index (PSQI) | The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality | At the time of enrollment |
| Pittsburgh sleep quality index (PSQI) | The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality | 24 weeks after enrollment |
| Pittsburgh sleep quality index (PSQI) | The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality | 48 weeks after enrollment |
| Stroke specific quality of life scale (SS-QOL) | The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life | At the time of enrollment |
| Stroke specific quality of life scale (SS-QOL) | The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life | 24 weeks after enrollment |
| Stroke specific quality of life scale (SS-QOL) | The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life | 48 weeks after enrollment |