Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke(AXAIS): A Multicenter, Randomized, Open-label, Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The change of NIHSS score
研究概览
简要总结
The main purpose of this trial is to analyse the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke by Metabonomics, proteomics and clinical parameters.
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. The primary hypothesis of this trial is that , Compared with the blank control group, Xingnaojing will produce serial changes in plasma and urine metabolites and biomarkers at baseline (pre-dose), 8 days and 11days . 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. The primary outcome will be determined at 11 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Acute ischemic stroke；
- •Symptom onset within 24 hours；
- •35 ≤ Age ≤ 80 years；
- •4 ≤ NIHSS ≤ 25；
- •Patient or legally authorized representative has signed informed consent.
排除标准
- •Expected length of hospital stay is less than 10 days;
- •Planned or already receiving intravenous thrombolysis or endovascular treatment;
- •Use of drugs with unknown composition within 1 week before enrollment;
- •Patients with acute infectious diseases (e.g. acute pneumonia) or taking related drugs within 1 month before treatment in the group;
- •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;
- •Currently receiving an investigational drug.
研究组 & 干预措施
Xingnaojing injection
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Interventions:
Drug: Xingnaojing injection Other: Standard care
干预措施: Xingnaojing injection (Drug)
结局指标
主要结局
The change of NIHSS score
时间窗: Baseline, 3 days, 7 days and 10 days
The NIHSS score ranges from 0 (best score) to 42 (worst score).
次要结局
- The proportion of NIHSS score from 0 to 1(Baseline, 3 days, 7 days and 10 days)
- Patient reported outcome (PRO) scale of stroke(10 days)
- Activities of daily living(30 days and 90 days)
- The proportion of patients independent at 30 days and 90 days(30 days and 90 days)
- Cardio-cerebral vascular incident(Within baseline and 90 days)
- The difference in proteomic and metabolomics(baseline (pre-dose), 7 days and 11days)
- State of consciousness(Baseline, 3 days, 7 days and 10 days)
- Safety end points(10 days)
- Stroke related deaths and deaths from any cause(Within 10 days and 90 days)
研究者
Ying Gao
Principal Investigator, Clinical Professor
Dongzhimen Hospital, Beijing