Clinical trial NCT01428401: Astragalus Membranaceus for Brain Edema Induced by Hemorrhagic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Hemorrhagic Transformation Due to Acute Stroke
Keywords: Complementary therapies
Acute hemorrhagic stroke
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-09-05
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: patients' scores(BI,FIM,GOS,mRS) on several clinical scales
timeFrame: 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).
Secondary outcomes:
measure: inflammatory index and Computer tomography (CT) examination
timeFrame: at baseline (prior to the first AM dose), and again on the fourth and seventh day of admission
Other outcomes:
Locations:
Study officials:
affiliation: d6407@mail.cmuh.org.tw
name: Chun Chung Chen, master
role: PRINCIPAL_INVESTIGATOR
References: