Acute Ischemic Stroke
Conditions
Brief summary
The purpose of this study is to assess the effectiveness and safety of Qingre Huatan formula versus placebo on preventing early neurological deterioration in patients with acute ischemic stroke within 48 hours after onset.
Interventions
DRUGQingre Huatan Formula
Qingre Huatan Formula, granules, 1 bag each time, twice a day, orally, continue for 10 days.
DRUGQingre Huatan Formula placebo
Qingre Huatan Formula placebo, granules, 1 bag each time, twice a day, orally, continue for 10 days.
Guidelines-based standard care for acute ischemic stroke
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 80 Years
Healthy volunteers
No
Inclusion criteria
1. Inpatients diagnosed with acute ischemic stroke. Inpatients diagnosed of acute ischemic stroke. 2. Meet the criteria of TCM phlegm-heat syndrome 3. Patients at high-risk of END : Magnetic resonance imaging (MRI) reveals new ischemic lesions, with DWI-ASPECTS score ≤ 7, or presence of at least two risk factors of END. 4. Acute ischemic stroke within 48 hours after onset. 5. Aged 18-80 years, male or female. 6. The patient or representative has signed informed consent.
Exclusion criteria
1. Received or planned thrombolysis or endovascular therapy after onset. 2. Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc. 3. Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 ) 4. Diseases that cause motor dysfunction, including osteoarthritis, etc. 5. Known severe liver or kidney dysfunction (alanine aminotransferase or aspartate transaminase \> 2 times the upper limit of normal value, serum creatinine \> 1.5 times the upper limit of normal value) 6. Known severe aphasia or mental illness affecting clinical information collection and evaluation. 7. Pregnancy, potential pregnancy or breastfeeding. 8. Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of early neurological deterioration within 7 days of onset | Basline and Day 7 | An increase of NIHSS ≥2 within 7 days of onset is considered as early neurological deterioration. The NIHSS (National Institute of Health Stroke Scale) is a neurological assessment tool for stroke patients, with scores ranging from 0 to 42. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with modified Rankin Scale score ≤2 on day 30 | Day 30 | The mRS (modified Rankin Scale) is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death). |
| The proportion of patients with modified Rankin Scale score ≤2 on day 90 | Day 90 | The mRS (modified Rankin Scale) is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death). |
| Change in National Institute of Health Stroke Scale scores from baseline to 10 days (after the treatment) | Basline and 10 days after treatment initiation | The NIHSS (National Institute of Health Stroke Scale) is a neurological assessment tool for stroke patients, with scores ranging from 0 to 42. Scores of 0-1 indicate near normal status, 1-4 mild stroke, 5-15 moderate stroke, 16-20 moderate-to-severe stroke, and 21-42 severe stroke. It is primarily used to quickly assess stroke severity and guide treatment decisions. |
| Activity of daily living of patients measured by Barthel Index score on day 90 | Day 90 | Barthel Index is 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). |
| Incidence of treatment-related adverse events | 90 days after treatment initiation | Number of patients with any adverse events during the study. |
| Activity of daily living of patients measured by Barthel Index score on day 30 | Day 30 | Barthel Index is 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). |
Countries
China
Outcome results
None listed