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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Fudan University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00815737
First received: December 29, 2008
Last updated: May 26, 2010
Last verified: September 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 29, 2008
Last Updated: May 26, 2010
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 26, 2014