A Phase IV, Double Blind, Placebo-controlled, Randomized, Multi-Center Study to Evaluate the Efficacy of Huatuo Zaizao Pills in Improving of Neural Function in Acute Ischemic Stroke
试验速览
- 阶段
- 4 期
- 入组人数
- 1,100
- 试验地点
- 4
- 主要终点
- modified Rankin Scale
研究概览
简要总结
The purpose of this study is to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China.
详细描述
Huatuo Zaizao Pills is a pure natural preparation from plant origin and consists of Chuanxiong rhizome, Evodia fruit and etc. Most of its ingredients are not opened and reserved by the National Commission for Science and Technology and the State Food and Drug Administration.
Huatuo Zaizao Pills was approved for marketing as a drug over several decades for treating and preventing cardiovascular and cerebrovascular diseases and their sequela. It is used to symptoms induced by blood stasis or stagnation of phlegm-wetness, such as stroke and paralysis, stiffness and numbness, deviation of the eye and mouth and dysphasia.
Based on the history of Huatuo Zaizao Pills for the treatment of cerebral infarction and hemorrhagic stroke, investigators will perform a phase IV, double blind, placebo-controlled, randomized and multi-Center clinical trial in China to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China.
The study was designed with a target sample size of 1100 patients and the investigators will perform 200 patients in the first period. Patients will be randomly assigned to receive Huatuo Zaizao Pills or placebo at dose of 12g each time, twice daily.
The investigators hypothesis that this study might offer based medicine evidence to test and verified the efficacy of Huatuo Zaizao Pills in improving the neural function and life quality in patients with ischemic stroke.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be between the ages of 18 and 70 years.
- •Patient must be with ischemic stroke and at stroke onset 14th day.
- •Patient must be with mRS score <5 at enrollment and mRS score ≤1 before stroke onset.
- •Symptoms and imaging of CT (computed tomography) or MRI (Magnetic Resonance Imaging) support the diagnosis of ischemic stroke.
- •Patient must be with 4 ≤ NIHSS ≤
- •Patient must be with Glasgow coma scale (GCS) ≥
- •Only patient with an anterior circulation infarction of Oxfordshire Community Stroke Project (OCSP)classification and atherothrombosis or cardioembolism of modified TOAST classification were accepted.
- •Patient must understand and be willing, able and likely to comply with all study requirements.
- •Informed consent must be obtained.
排除标准
- •Patient with severe cognitive impairment who not be able to give voluntary written informed consent or participate in this study.
- •Maybe not to comply with all study requirements or not be able to participate in this study for regional or social reasons.
- •Pregnancy, breast feeding and the possible pregnancy during study.
- •Participating in another medicine or interference study in the same time or at least within 3 months, or enrolled in this study in other location.
- •Patient with mRS≥5 at enrollment.
- •Coma patient with GCS<
- •Patient with severe cerebral function impairment which was not caused by stroke.
- •Patient with dysphagia, Wyatt score ≥
- •Lacunar infarction.
- •Patient accompanied with systemic diseases: gastrointestinal hemorrhage, advanced carcinoma, liver malfunction, kidney malfunction, severe dementia or mental disorder.
- •Unstable patient after receiving thrombolytic therapy.
- •Cerebral hemorrhage verified by CT or MRI.
- •History of major operation or trauma within 6 weeks or having a major operation arrangement.
- •Allergic to one or more components of study medicine.
- •Receiving study medicine or components of study medicine within 2 weeks.
研究组 & 干预措施
Placebo Pills
- 12 g each time, twice daily.
- 3 months
干预措施: Huatuo Zaizao Pills (Drug)
Huatuo Zaizao Pills
- 12 g each time, twice daily.
- 3 months.
干预措施: Huatuo Zaizao Pills (Drug)
结局指标
主要结局
modified Rankin Scale
时间窗: 3 months
The primary end point is the proportion of patients with a modified Rankin Scale (mRS) score of 0 to 1 at 3 months.
次要结局
- modified Rankin Scale,NIHSS, Barthel Index, and MMSE(3 months)