Ischemic Stroke
Conditions
Keywords
acute ischemic stroke, traditional Chinese medicine, registry study
Brief summary
The primary purpose of this study is to investigate the effectiveness and safety of the Suhexiang Pill for patients with acute ischemic stroke in real-world settings.
Detailed description
Suhexiang Pill, a traditional Chinese patent medicine, is widely used in China for acute stroke. However, there is a lack of evidence of its efficacy and safety for acute ischemic stroke in real-world setting. This registry study will recruit 1000 patients who receive Suhexiang Pill treatment after acute ischemic stroke.
Interventions
DRUGSuhexiang Pill
Suhexiang Pill is an approved traditional Chinese patent medicine.
Sponsors
Dongzhimen Hospital, Beijing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute ischemic stroke within 7 days of symptom onset. * Age ≥ 18 * Patient who has received Suhexiang Pill treatment * Patient or legally authorized representative has signed informed consent.
Exclusion criteria
* Be allergic to Suhexiang Pill * Known to be pregnant or breastfeeding. * With conditions that render outcomes or follow-up unlikely to be assessed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients independent | 90 days | Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Institute of Health Stroke Scale | The change from baseline to day 10 or discharge. | The National Institute of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurological deficits. |
| Glasgow Coma Scale | The change from baseline to day 10 or discharge. | The Glasgow Coma Scale (GCS) is used to describe the extent of impaired consciousness in all types of acute medical and trauma patients, ranging from 0 to 15, with lower scores indicating more severe impaired consciousness. |
| Patient reported outcome | At day 10 or discharge. | The patient reported outcome (PRO) scale of stroke consists of four dimensions including the influence on physical, emotional, and social functioning, as well as the overall satisfaction with treatment. |
Countries
China
Outcome results
None listed