Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From a Stroke

Study Overview
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Brief Summary
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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.

Conditions
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Pneumonia, Acute Stroke

Intervention / Treatment
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* Drug: rhubarb
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>rhubarb | Drug: rhubarb<br>* 14 days of rhubarb<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* 14 days of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The lung infection rate within 14 days after stroke onset |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung infection after ischemic Stroke, prevention of pneumonia, rhubarb