Clinical Re-evaluation of Removing Blood Stasis Therapy of Herbal Medicine in Treating Acute Cerebral Hemorrhage Safety
试验速览
- 阶段
- 4 期
- 入组人数
- 360
- 试验地点
- 15
- 主要终点
- Hematoma enlargement
研究概览
简要总结
In order to investigate the time window of acute intracerebral hemorrhage(AICH) by "Blood Activating and Stasis Dispersing" therapy and to verify traditional methods if it would influence or enlarge the brain hematoma, test is made by random double-blind controlled. Patients are classified to （0-6h）and (6-72h) teams. Herbs is separated too. The period of the therapy lasts two weeks, and the follow up should last three months. The main indexes are mortality rate, disability rate and the brain hematoma situation. The review is made by the reference to (NIHSS),(GCS) and so on. So, the window time is determined through this test.
详细描述
objective
to investigate the safety and effect of acute cerebral hemorrhage treated with "Blood Activating and Stasis Dispersing" therapy and to verify the traditional methods can influence the brain hematoma enlargement or not.
Methods: from 2013.8 to 2015.12, 360 cases of AICH will be included in 13 research centers. Patients are randomly into 3 groups within 6hrs from onset,such as, group A, blood activating herbal medicine (8 herbals), Group B, herbal medicine without blood activating herbal(6 herbals), Group C, placebo for 10days. All the patients will be treated according AHA guideline of AICH. All patients will be set to the CT at the onset, 24h later and 10-14days after treatment. So the rate of enlargement of brain hematoma in the 72h later, mortality rate in the two weeks and the disability rate in the 90 days can be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no younger than 18 yrs
- •acute cerebral hemorrhage confirmed by brain CT scan
- •within 6 hours from onset
- •Sign the informed consent form
排除标准
- •Tests have confirmed that cerebral hemorrhage caused by brain tumor, blood diseases, cerebrovascular malformation (anomaly) or aneurysm, etc;
- •patients with Severe heart, liver and renal insufficiency.
- •Intolerance to traditional Chinese medicine (TCM), allergic constitution.
- •patients with severe cerebral hernia in the early onset
- •Compliance is poor.
研究组 & 干预措施
ICH-1
herbal medicine with Hirudo, Tabanus,8 herbals, promote blood circulation function
干预措施: ICH-1(herbal medicine with Hirudo, Tabanus) (Drug)
ICH-2
herbal medicine without Hirudo, Tabanus,Only 6 herbals
干预措施: ICH-2(herbal medicine without Hirudo, Tabanus) (Drug)
placebo herbal medicine
Placebo ：granula，dose twice a day by Oral or nasogastric tube for 10 days
干预措施: placebo (Drug)
结局指标
主要结局
Hematoma enlargement
时间窗: 24hrs, 10-14days
次要结局
- fatality rate(3 month)
- modified rankin scale(3 months)
- National Institute of Health of stroke scale(10-14days, 90days)