Astragalus Membranaceus for Brain Edema Induced by Hemorrhagic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- patients' scores(BI,FIM,GOS,mRS) on several clinical scales
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female or male;
- •aged between 30 and 75 years;
- •randomized allocation to a study group within 24 hours of hemorrhagic stroke onset;
- •this was the patient's first hemorrhagic stroke, and the location of hemorrhage was the putamen;
- •treatment may or may not have been included surgery; and
- •the subject or their legal representative gave written informed consent to participate.
排除标准
- •recent thrombolysis treatment;
- •history of previous stroke;
- •full-dose or long-term anti-coagulation therapy;
- •hemorrhagic stroke but the location was not putamen;
- •coexisting systemic diseases such as terminal cancer, renal failure, liver cirrhosis, severe dementia, or psychosis;
- •participation in another clinical trial within the last three months; and
- •pregnancy or lactation.
研究组 & 干预措施
Arm A
干预措施: Chinese Herb Astragalus membranaceus (Drug)
Arm B
干预措施: Placebo (Other)
结局指标
主要结局
patients' scores(BI,FIM,GOS,mRS) on several clinical scales
时间窗: 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.
次要结局
- inflammatory index and Computer tomography (CT) examination(at baseline (prior to the first AM dose), and again on the fourth and seventh day of admission)