Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From Cerebral Hemorrhage

Pneumonia Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00815737
• Other study ID #: rhubarb cerebral hemorrhage
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: December 29, 2008
• Last updated: May 26, 2010
• Start date: January 2009

Study information

• Verified date: September 2009
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Lung Infection
• Pneumonia

Intervention

Drug:
• rhubarb
14 days of rhubarb
• Placebo
14 days of Placebo

Locations

Country	Name	City	State
China	Zhongshan hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

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