Pneumonia, Acute Stroke
Conditions
Keywords
lung infection after ischemic Stroke, prevention of pneumonia, rhubarb
Brief summary
This study will determine if rhubarb will reduced the incidence of pneumonia and improved recovery from an acute stroke. The study is designed to look at both infection rate and overall recovery and recovery of motor function, for example muscle strength and coordination.
Interventions
DRUGrhubarb
14 days of rhubarb
DRUGplacebo
14 days of placebo
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Occurrence of an acute ischemic stroke (between 9 and 72 h after onset) with a score of at least 6 on the National Institute of Health Stroke Scale (NIHSS), and patient age of at least 18 years. * Have no pneumonia according to modified criteria of the U.S. Centers for Disease Control and Prevention (CDC) * Consistent with the Constipation of Phlegm-Heat Accumulation type by Traditional Chinese Medicine (TCM) standard * Patients or their representatives voluntarily take part in this study and signed the informed consent
Exclusion criteria
* Cerebral hemorrhage, subarachnoid hemorrhage * Transient ischemic attack(TIA) * Proven cerebral embolism caused by tumor, Brain Trauma, cerebral parasitic disease, dysbolismus, fibrillation atrial resulted from rheumatic heart disease, coronary heart disease, and other heart diseases * Clinical signs of infection on admission * Pregnant or breast-feeding * Allergic to rhubarb * Preceding or ongoing antibiotic therapy within the last 24 h * Participation in another interventional trial * Immunosuppressant treatment within the last 30 days * Combining severe clinical conditions such as liver, kidney, Hematopoietic System, endocrine system or psychological diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The lung infection rate within 14 days after stroke onset | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| NIH stroke scale | 90 days |
| Barthel Index | 90 days |
| Global disability on modified Rankin scale | 90 days |
| Syndrome score by Traditional Chinese Medicine (TCM) standard | 90 days |
| Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transaminase (ALT), aspartate transaminase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples, etc. | 90 days |
| Death rate | 90 days |
Countries
China
Outcome results
None listed