Analyzing the Pharmacodynamic Substances and the Effects of Xingnaojing for Mild-to-Severe Acute Ischemic Stroke (PUBLISH): A Non-randomized, Open-label, Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 7 days.
Study Overview
Brief Summary
The main purposes of this trial are to analyze the pharmacodynamic substances and the effects of Xingnaojing for mild-to-severe acute ischemic stroke.
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. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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)
Intervention: Xingnaojing injection (Drug)
Outcomes
Primary Outcomes
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 7 days.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Ying Gao
Professor
Dongzhimen Hospital, Beijing