Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From a Stroke
- Registration Number
- NCT00789269
- Lead Sponsor
- Fudan University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 placebo - 1 rhubarb rhubarb
- Primary Outcome Measures
Name Time Method The lung infection rate within 14 days after stroke onset 14 days
- Secondary Outcome Measures
Name Time Method Global disability on modified Rankin scale 90 days NIH stroke scale 90 days Barthel Index 90 days Death rate 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
Trial Locations
- Locations (1)
Department of Integrative Medicine, Zhongshan hospital, Fudan University
🇨🇳Shanghai, Shanghai, China