Rhubarb for the Treatment of Patients Who Have Suffered from cerebral hemorrhage

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Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From Cerebral Hemorrhage - Full Text View -
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Placebo Comparator: B
Eligibility
Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: Criteria Inclusion Criteria: Occurrence of an acute cerebral hemorrhage (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 infarction, transient ischemic attack(TIA) Subarachnoid hemorrhage 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 18 Years and older Both No
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Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From Cerebral Hemorrhage
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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
Further study details as provided by Fudan University: Primary Outcome Measures: The lung infection rate within 14 days after stroke onset [ Time Frame: 14 days ] [ Designated as safety issue: No ] Secondary Outcome Measures: Global disability on modified Rankin scale at 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ] NIH stroke scale [ Time Frame: 90 days ] [ Designated as safety issue: No ] Barthel Index [ Time Frame: 90 days ] [ Designated as safety issue: No ] Death rate [ Time Frame: 90 days ] [ Designated as safety issue: No ] Syndrome score by Traditional Chinese Medicine (TCM) standard [ Time Frame: 90 days ] [ Designated as safety issue: No ] 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; protein, [ Time Frame: 90 days ] [ Designated as safety issue: Yes ] Estimated Enrollment: Study Start Date: Arms Experimental: A 100 January 2009 Assigned Interventions Drug: rhubarb 14 days of rhubarb Drug: Placebo 14 days of Placebo
/ct2/show/NCT00815737?term=Stroke+AND+pneumonia&rank=6[2012-6-25 14:24:54]
Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From Cerebral Hemorrhage - Full Text View -
Fudan University Fudan University NCT00815737
Purpose
This study will determine if rhubarb will reduced the incidence of pneumonia and improved recovery from an acute cerebral hemorrhage. The study is designed to look at both infection rate and overall recovery and recovery of motor function, for example muscle strength and coordination. Condition Lung Infection Cerebral Hemorrhage Pneumonia Study Type: Study Design: Intervention Drug: rhubarb Drug: Placebo Phase Phase 2 Phase 3
/ct2/show/NCT00815737?term=Stroke+AND+pneumonia&rank=6[2012-6-25 14:24:54]
Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From Cerebral Hemorrhage - Full Text View -
Contacts and Locations
Please refer to this study by its identifier: NCT00815737
Locations China, Shanghai Zhongshan hospital of Fudan University Shanghai, Shanghai, China, 200032 Sponsors and Collaborators Fudan University