Clinical trial NCT04813445: Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke
Official title: Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke(AXAIS): A Multicenter, Randomized, Open-label, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Stroke
Ischemic Stroke
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Nantong University
name: Nanjing Brian Hospital
name: Affiliated Hospital of Chengde Medical University
First posted: 2021-03-24
Enrollment: 72
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The change of NIHSS score
timeFrame: Baseline, 3 days, 7 days and 10 days
Secondary outcomes:
measure: The proportion of NIHSS score from 0 to 1
timeFrame: Baseline, 3 days, 7 days and 10 days
measure: Patient reported outcome (PRO) scale of stroke
timeFrame: 10 days
measure: The proportion of patients independent at 30 days and 90 days
timeFrame: 30 days and 90 days
measure: Cardio-cerebral vascular incident
timeFrame: Within baseline and 90 days
measure: The difference in proteomic and metabolomics
timeFrame: baseline (pre-dose), 7 days and 11days
measure: State of consciousness
timeFrame: Baseline, 3 days, 7 days and 10 days
measure: Activities of daily living
timeFrame: 30 days and 90 days
measure: Safety end points
timeFrame: 10 days
measure: Stroke related deaths and deaths from any cause
timeFrame: Within 10 days and 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
Study officials:
References: