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Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From a Stroke

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
Information provided by:
Fudan University Identifier:
First received: November 10, 2008
Last updated: May 26, 2010
Last verified: September 2009
This study will determine if rhubarb will reduced the incidence of pneumonia and improved recovery from an acute stroke. 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
Pneumonia Acute Stroke Drug: rhubarb Drug: placebo Phase 2

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

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 [ 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, etc. [ Time Frame: 90 days ]

Estimated Enrollment: 100
Study Start Date: January 2009
Arms Assigned Interventions
Experimental: 1
Drug: rhubarb
14 days of rhubarb
Placebo Comparator: 2 Drug: placebo
14 days of placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Occurrence of an acute ischemic stroke (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 hemorrhage, subarachnoid hemorrhage
  • Transient ischemic attack(TIA)
  • 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
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Please refer to this study by its identifier: NCT00789269

China, Shanghai
Department of Integrative Medicine, Zhongshan hospital, Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
  More Information

Responsible Party: Zhongshan hospital, Fudan University, TCM department, Zhongshan hospital, Fudan University Identifier: NCT00789269     History of Changes
Other Study ID Numbers: rhubarb ischemia
Study First Received: November 10, 2008
Last Updated: May 26, 2010

Keywords provided by Fudan University:
lung infection after ischemic Stroke
prevention of pneumonia

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on August 18, 2017