Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From a Stroke - Full Text View

Sponsored by:	Fudan University
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00789269

Purpose

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 II

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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 [ 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 transarninase(ALT), aspartate transarninase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples; protein, red b [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:

100

Arms	Assigned Interventions
1: Experimental rhubarb	Drug: rhubarb 14 days of rhubarb
2: Placebo Comparator	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 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
Transiant 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789269

Contacts

Contact: Dingfang Cai, MD

021-64041990

doctorcn@hotmail.com

Locations

China
Department of Integrative Medicine, Zhongshan hospital, Fudan University
Shanghai, China, 200032

Sponsors and Collaborators

Fudan University

More Information

Study ID Numbers:	rhubarb ischemia
Study First Received:	November 10, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00789269
Health Authority:	China: Ethics Committee

Keywords provided by Fudan University:

lung infection after ischemic Stroke
prevention of pneumonia
rhubarb

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Cerebral Infarction
Lung Diseases
Stroke
Vascular Diseases

Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Pneumonia

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009