Astragalus Membranaceus for Brain Edema Induced by Hemorrhagic Stroke

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428401
• Other study ID #: DMR96-IRB-126
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2011
• Last updated: September 2, 2011
• Start date: January 2008
• Est. completion date: March 2011

Study information

• Verified date: September 2011
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Chinese Medicine and Pharmacy, Department of the Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hemorrhagic Transformation Due to Acute Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients' scores(BI,FIM,GOS,mRS) on several clinical scales	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.	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).	Yes
Secondary	inflammatory index and Computer tomography (CT) examination	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; 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)	at baseline (prior to the first AM dose), and again on the fourth and seventh day of admission	Yes