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Astragalus Membranaceus for Brain Edema Induced by Hemorrhagic Stroke

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.
 
ClinicalTrials.gov Identifier: NCT01428401
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : September 5, 2011
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Tracking Information
First Submitted Date  ICMJE September 1, 2011
First Posted Date  ICMJE September 5, 2011
Last Update Posted Date September 5, 2011
Study Start Date  ICMJE January 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2011)
patients' scores(BI,FIM,GOS,mRS) on several clinical scales [ Time Frame: baseline (within 7 ± 1 days after the onset of stroke) and week 4 (28 ± 4 days), and between at baseline and week 12 (84 ± 10 days). ]
The primary outcome measures were the differences in patients' scores on several clinical scales, between baseline (within 7 ± 1 days after the onset of stroke) and week 4 (28 ± 4 days), and between at baseline and week 12 (84 ± 10 days). The scales we used were the Functional Independence Measure scale (FIM), Barthel Index scale (BI), Glasgow Outcome Scale (GOS), and Modified Rankin Scale (MRS). The scores of FIM, BI, GOS, and MRS were assessed by an experienced research nurse.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2011)
inflammatory index and Computer tomography (CT) examination [ Time Frame: at baseline (prior to the first AM dose), and again on the fourth and seventh day of admission ]
  1. inflammatory index, which included the levels of C-reactive protein (CRP) and erythrocyte sediment rate (ESR) for venous blood; these were measured at baseline (prior to the first AM dose), and again on the fourth and seventh day of admission; and
  2. Computer tomography (CT) examination, which was done at baseline and on the fourth and seventh days of admission. The ratio of brain edema was calculated by CT (volume of edema divided by blood clot volume)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Astragalus Membranaceus for Brain Edema Induced by Hemorrhagic Stroke
Official Title  ICMJE Not Provided
Brief Summary

Astragalus membranaceus (AM) is used to treat stroke for a long period, and a number of studies have known that AM can reduce cerebral infarction area and has anti-oxidation. Hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase intracranial pressure to exacerbate clinical symptom. Therefore, the purpose of the present study was to investigate the effect of AM on hemorrhagic stroke edema. The investigators selected 80 hemorrhagic stroke patients , and who the stroke is first attack, they were randomly divided into control and experimental groups, and each group was 40 patients as follows: 1) control group, accepted AM placebo 2.8 g three times per day (tid) treatment for continuously 14 days from second day of admission or operation, except standard ordinary treatment; 2) experimental group, accepted AM 2.8 g tid treatment for continuously 14 days from second day of admission or operation, except standard ordinary treatment. Computer tomography (CT) examination was done at first day, 4th day and 7th day of admission, respectively. The ratio of brain edema was calculated by CT image, and inflammatory index including the levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR),Creatine Kinase BB Isoenzyme (CMBB). D-dimer from venous blood also were measured. In addition, the score including Glasgow outcome scale (GOS), Modified rankin scale (MRS), Function independence measure (FIM), Barthel index (BI) was recorded one week, four weeks and 12 weeks after admission or surgical operation, as an index for clinical symptoms. The index for the therapeutic effect of AM was according to above-mentioned the ratio of brain edema, inflammatory index and clinical symptoms.

The investigators expected the results of the present study may provide a scientific evidence for the hemorrhagic stroke edema treatment of AM, thus, the present study may contribute to use the method of integrated Chinese and Western Medicine for the treatment of stroke, and to the research of Chinese Medicine.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Hemorrhagic Transformation Due to Acute Stroke
Intervention  ICMJE
  • Drug: Chinese Herb Astragalus membranaceus
    Astragalus membranaceus ( AM) at a rate of 3 g three times per day
  • Other: Placebo
    at a rate of 3 g three times per day
Study Arms  ICMJE
  • Experimental: Arm A
    Intervention: Drug: Chinese Herb Astragalus membranaceus
  • Placebo Comparator: Arm B
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2011)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. female or male;
  2. aged between 30 and 75 years;
  3. randomized allocation to a study group within 24 hours of hemorrhagic stroke onset;
  4. this was the patient's first hemorrhagic stroke, and the location of hemorrhage was the putamen;
  5. treatment may or may not have been included surgery; and
  6. the subject or their legal representative gave written informed consent to participate.

Exclusion Criteria:

  1. recent thrombolysis treatment;
  2. history of previous stroke;
  3. full-dose or long-term anti-coagulation therapy;
  4. hemorrhagic stroke but the location was not putamen;
  5. coexisting systemic diseases such as terminal cancer, renal failure, liver cirrhosis, severe dementia, or psychosis;
  6. participation in another clinical trial within the last three months; and
  7. pregnancy or lactation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01428401
Other Study ID Numbers  ICMJE DMR96-IRB-126
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party China Medical University Hospital
Study Sponsor  ICMJE China Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chun Chung Chen, master d6407@mail.cmuh.org.tw
PRS Account China Medical University Hospital
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP