Pneumonia Clinical Trial
Verified date | September 2009 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Zhongshan hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The lung infection rate within 14 days after stroke onset | 14 days | No | |
Secondary | Global disability on modified Rankin scale at 90 days | 90 days | No | |
Secondary | NIH stroke scale | 90 days | No | |
Secondary | Barthel Index | 90 days | No | |
Secondary | Death rate | 90 days | No | |
Secondary | Syndrome score by Traditional Chinese Medicine (TCM) standard | 90 days | No | |
Secondary | 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, | 90 days | Yes |
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