Analyzing the Pharmacodynamic Substances and the Effects of Xingnaojing for Mild-to-Severe Acute Ischemic Stroke (PUBLISH): A Non-randomized, Open-label, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 7 days.
研究概览
简要总结
The main purposes of this trial are to analyze the pharmacodynamic substances and the effects of Xingnaojing for mild-to-severe acute ischemic stroke.
详细描述
Xingnaojing is widely used in China, but there is lack of sufficient and reasonable explanation of its intervention effects for acute ischemic stroke currently. In order to further clarify the main pharmacodynamic substances of Xingnaojing in the treatment of acute ischemic stroke, this study intends to carry out a non-randomized, open-label, controlled clinical trial. The primary hypothesis is that , compared with the control group, Xingnaojing will produce serial changes in plasma metabolites at baseline (pre-dose) and 7 days, as well as urine metabolites at baseline (pre-dose), 6 days, 7 days and 8 days. The serial changes may be the potential support to explain the intervention effect of Xingnaojing. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded.
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 within 24 hours；
- •40 ≤ age ≤ 80 years;
- •4 ≤ NIHSS ≤ 25；
- •Patient or legally authorized representative has signed informed consent.
排除标准
- •Planned or already receiving intravenous thrombolysis or endovascular treatment;
- •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 cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);
- •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;
- •Use any drugs containing traditional Chinese medicine within 1 week before enrollment;
- •Currently receiving an investigational drug.
研究组 & 干预措施
Xingnaojing injection group
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Interventions:
Drugs:Xingnaojing injection Other: Standard care (eg. antiplatelet drugs and statins)
干预措施: Xingnaojing injection (Drug)
结局指标
主要结局
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 7 days.
时间窗: 7 days
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 7 days.
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at baseline.
时间窗: Baseline
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at baseline.
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 6 days.
时间窗: 6 days
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 6 days.
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 8 days.
时间窗: 8 days
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 8 days.
次要结局
- Patient reported outcome(7 days)
- Number of participants with cerebral vascular incidents(90 days)
- The change of neurological deficits(Baseline, 7 days)
- The proportion of life dependency(30 days, 90 days)
- The degree of disability(30 days, 90 days)
- Number of participants with cardio-cerebral vascular incidents(90 days)
研究者
Ying Gao
Professor
Dongzhimen Hospital, Beijing