Clinical trial NCT00815737: Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From Cerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Lung Infection
Cerebral Hemorrhage
Pneumonia
Keywords: Lung Infection After Cerebral Hemorrhage
Prevention of Pneumonia
Rhubarb
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2008-12-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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
* 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

Primary outcomes:
measure: The lung infection rate within 14 days after stroke onset
timeFrame: 14 days
Secondary outcomes:
measure: Global disability on modified Rankin scale at 90 days
timeFrame: 90 days
measure: NIH stroke scale
timeFrame: 90 days
measure: Barthel Index
timeFrame: 90 days
measure: Death rate
timeFrame: 90 days
measure: Syndrome score by Traditional Chinese Medicine (TCM) standard
timeFrame: 90 days
measure: 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,
timeFrame: 90 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital of Fudan University
state: Shanghai
Study officials:
References:
citation: Cai DF, Dai W, Chen YP, Wen M, Dai HL. [Effect and mechanism of rhubarb on fibrinolysis in secondary damaged central nerve system of rats with acute hemorrhagic stroke]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2005 Jan;25(1):38-41. Chinese.