Analyzing the Pharmacodynamic Substances and the Effects of Xingnaojing for Mild-to-Severe Acute Ischemic Stroke (PUBLISH)

Ying Gao

Status and phase: Enrolling; Phase 4

Conditions: Ischemic Stroke, Acute

Treatments: Drug: Xingnaojing injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05559307

2018YFC1705001-05-02

Details and patient eligibility

About

The main purposes of this trial are to analyze the pharmacodynamic substances and the effects of Xingnaojing for mild-to-severe acute ischemic stroke.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Xingnaojing injection group

Experimental group

Description:

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)

Treatment:

Drug: Xingnaojing injection

Standard care group

No Intervention group

Description:

Subjects will receive guidelines-based standard care. Interventions: Other: Standard care (eg. antiplatelet drugs and statins)