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Astragalus Membranaceus for Brain Edema Induced by Hemorrhagic Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01428401
First received: September 1, 2011
Last updated: September 2, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Stroke
Hemorrhagic Transformation Due to Acute Stroke
Drug: Chinese Herb Astragalus membranaceus
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 80
Study Start Date: January 2008
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: Chinese Herb Astragalus membranaceus
Astragalus membranaceus ( AM) at a rate of 3 g three times per day
Placebo Comparator: Arm B Other: Placebo
at a rate of 3 g three times per day

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01428401

Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Chun Chung Chen, master d6407@mail.cmuh.org.tw
  More Information

No publications provided

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01428401     History of Changes
Other Study ID Numbers: DMR96-IRB-126
Study First Received: September 1, 2011
Last Updated: September 2, 2011
Health Authority: Taiwan: Chinese Medicine and Pharmacy, Department of the Health

Keywords provided by China Medical University Hospital:
Complementary therapies
Acute hemorrhagic stroke

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014