Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke

Not Applicable

• Conditions: Ischemic Stroke; Acute Stroke
• Interventions: Drug: Xingnaojing injection

• Registration Number: NCT04813445
• Lead Sponsor: Dongzhimen Hospital, Beijing

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.

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-21
• Study First Posted: 2021-03-24
• Study Start: 2021-05-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-18
• Primary Completion: 2022-06-28
• Study Completion: 2022-09-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xingnaojing injection	Xingnaojing injection	Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Interventions: Drug: Xingnaojing injection Other: Standard care

Primary Outcome Measures

Name	Time	Method
The change of NIHSS score	Baseline, 3 days, 7 days and 10 days	The NIHSS score ranges from 0 (best score) to 42 (worst score).

Secondary Outcome Measures

Name	Time	Method
The proportion of NIHSS score from 0 to 1	Baseline, 3 days, 7 days and 10 days	The NIHSS score ranges from 0 (best score) to 42 (worst score).
Patient reported outcome (PRO) scale of stroke	10 days	Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 0(worst score) to 180 (best score).
Activities of daily living	30 days and 90 days	Activities of daily living will be measured by Barthel Index score at 30 days and 90 days.The Barthel Index score ranges from 0 (worst score) to 100 (best score).
The proportion of patients independent at 30 days and 90 days	30 days and 90 days	The proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2. The mRS score ranges from 0 (best score) to 6 (worst score).
Cardio-cerebral vascular incident	Within baseline and 90 days	Cardio-cerebral vascular incident were defined as stroke, acute coronary syndrome (acute ST-elevation myocardial infarction, acute non-ST-elevation myocardial infarction and unstable angina), vascular death, etc.
The difference in proteomic and metabolomics	baseline (pre-dose), 7 days and 11days	Through proteomics and metabonomics to explore whether there are different metabolites or proteins between the two groups.（It's not known whether there are differences in the human body between the two groups.We are in the exploratory stage.）
State of consciousness	Baseline, 3 days, 7 days and 10 days	The state of consciousness evaluated by Glasgow Coma Scale at Baseline, 3 days, 7 days and 10 days. The Glasgow score ranges from 3(worst score) to 15 (best score).
Safety end points	10 days	Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).
Stroke related deaths and deaths from any cause	Within 10 days and 90 days	Stroke related deaths and deaths from any cause within 10 days and 90 days after symptom onset.

Trial Locations

Locations (1)

Dongzhimen Hospital; 🇨🇳 Beijing, Beijing, China