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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Fudan University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00815737
First Posted: December 30, 2008
Last Update Posted: May 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fudan University
  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 Intervention Phase
Lung Infection Cerebral Hemorrhage Pneumonia Drug: rhubarb Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Global disability on modified Rankin scale at 90 days [ Time Frame: 90 days ]
  • NIH stroke scale [ Time Frame: 90 days ]
  • Barthel Index [ Time Frame: 90 days ]
  • Death rate [ Time Frame: 90 days ]
  • Syndrome score by Traditional Chinese Medicine (TCM) standard [ Time Frame: 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; protein, [ Time Frame: 90 days ]

Estimated Enrollment: 100
Study Start Date: January 2009
Arms Assigned Interventions
Experimental: A Drug: rhubarb
14 days of rhubarb
Placebo Comparator: B Drug: Placebo
14 days of Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815737


Locations
China, Shanghai
Zhongshan hospital of Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
  More Information

Publications:
Responsible Party: Zhongshan hospital, Fudan University, TCM department, Zhongshan hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00815737     History of Changes
Other Study ID Numbers: rhubarb cerebral hemorrhage
First Submitted: December 29, 2008
First Posted: December 30, 2008
Last Update Posted: May 28, 2010
Last Verified: September 2009

Keywords provided by Fudan University:
Lung Infection After Cerebral Hemorrhage
Prevention of Pneumonia
Rhubarb

Additional relevant MeSH terms:
Pneumonia
Hemorrhage
Cerebral Hemorrhage
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases