- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00789269
Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From a Stroke
May 26, 2010 updated by: Fudan University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Department of Integrative Medicine, Zhongshan hospital, Fudan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
14 days of placebo
|
Experimental: 1
rhubarb
|
14 days of rhubarb
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The lung infection rate within 14 days after stroke onset
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
NIH stroke scale
Time Frame: 90 days
|
90 days
|
Barthel Index
Time Frame: 90 days
|
90 days
|
Death rate
Time Frame: 90 days
|
90 days
|
Syndrome score by Traditional Chinese Medicine (TCM) standard
Time Frame: 90 days
|
90 days
|
Global disability on modified Rankin scale
Time Frame: 90 days
|
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
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Study Registration Dates
First Submitted
November 10, 2008
First Submitted That Met QC Criteria
November 10, 2008
First Posted (Estimate)
November 11, 2008
Study Record Updates
Last Update Posted (Estimate)
May 28, 2010
Last Update Submitted That Met QC Criteria
May 26, 2010
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- rhubarb ischemia
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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