Ischemic Stroke
Conditions
Keywords
ischemic stroke, LongShengZhi capsule, efficacy, safety, randomized controlled trial
Brief summary
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.
Interventions
DRUGLongShengZhi capsule
LongShengZhi capsules, orally, 5 capsules each time, three times a day.
DRUGLongShengZhi capsule placebo
LongShengZhi capsules placebo, orally, 5 capsules each time, three times a day.
Sponsors
Dongzhimen Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute ischemic stroke patients within 7 days of onset * 18 years of age or older, and gender not limited * NIHSS score of 4 to 15
Exclusion criteria
* Secondary stroke caused by a tumor, traumatic brain injury, hematological disease, or other diseases with a confirmed diagnosis * Pre-stroke mRS score of more than 1 * Known severe liver or kidney dysfunction * Known allergies for ingredients in the investigational product * Known bleeding diathesis or coagulation disorder * Known medical condition likely to limit survival to less than 3 months * Pregnant women (clinically evident) or breastfeeding women * Participation in any investigational study in the previous 3 months * Known dementia, uncontrolled psychiatric problems * Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. The judgment is left to the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with excellent outcome | 90 days after randomization | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with good outcome | 30 days after randomization | 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). |
| Changes in National Institutes of Health Stroke Scale (NIHSS) scores | 90 days after randomization | 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. |
| The proportion of patients with poor quality of life | 30 days after randomization | 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). |
| Distribution of the modified Rankin scale (mRS) scores | 30 days after randomization | 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. |
| Changes in Motor function | 90 days after randomization | 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. |
| Changes in Cognitive function | 90 days after randomization | 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. |
| The proportion of adverse events (AEs) | 90 days after randomization | The proportion of AEs during the treatment. |
| The proportion of patients with functional independence | 30 days after randomization | 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). |
Contacts
Primary ContactDandan Zhang, PhD, MD
Outcome results
None listed