Analyzing the Pharmacodynamic Substances and the Effects of Yiqihuayu Decotion for Acute Ischemic Stroke (PHYSIS): A Non-randomized, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Differences in Caffeic acid, Amygdalin, Paeoniflorin between experimental group and control group.
研究概览
简要总结
The main purposes of this trial are to analyze the pharmacodynamic substances and the effects of Yiqihuayu Decotion for acute ischemic stroke. The trial is a non-randomized, controlled clinical trial.
详细描述
Yiqihuayu Decotion is effective for acute ischemic stroke clinically, but there is lack of sufficient and reasonable explanation of its intervention effects currently. In order to further clarify the main pharmacodynamic substances of Yiqihuayu Decotion in the treatment of acute ischemic stroke, this study intends to carry out a non-randomized, controlled clinical trial. The primary hypothesis is that, compared with the control group, Yiqihuayu Decotion will produce serial changes in plasma metabolites at pre-dose and 9 days, as well as urine metabolites at pre-dose, 8 days, 9 days and 10 days. The serial changes may be the potential support to explain the intervention effect of Yiqihuayu Decotion. After enrollment, all participants will undergo a 2-day Traditional Chinese Medcine washout period to ensure that the results of pharmacodynamic substances will not be disturbed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Acute ischemic stroke;
- •Symptom onset of 4 to 6 days;
- •40 ≤ age ≤ 80 years;
- •Be conscious and able to cooperate with clinical information gatherers;
- •Patient or legally authorized representative has signed informed consent.
排除标准
- •Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
- •Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
- •Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
- •Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);
- •Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer)
- •Other conditions that render outcomes or follow-up unlikely to be assessed;
- •Known to be pregnant or breastfeeding;
- •Participating in another clinical study.
研究组 & 干预措施
Experimental group
Experimental: Experimental group Subjects will receive Yiqihuayu Decotion, combined with guidelines-based standard care.
Interventions:
Drugs: Yiqihuayu Decotion Other: Standard care (e.g. antiplatelet drugs and statins)
干预措施: Yiqihuayu Decotion (Drug)
结局指标
主要结局
Differences in Caffeic acid, Amygdalin, Paeoniflorin between experimental group and control group.
时间窗: 3 days, 8 days, 9 days, 10 days
Differences in the content of Caffeic acid, Amygdalin, Paeoniflorin in plasma and urine samples between experimental group and control group.
次要结局
- The proportion of life dependency(1 day, 30 days)
- The change of neurological deficits(1 day, 3 days, 9 days)
研究者
Ying Gao
Professor
Dongzhimen Hospital, Beijing