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

NCT ID: NCT05559307

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-16
• Study Completion Date: 2023-03-31

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.

Conditions

Ischemic Stroke, Acute

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Xingnaojing injection

Intervention Type: DRUG

Xingnaojing injection 20 ml+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 7 days.

Standard care group

Subjects will receive guidelines-based standard care.

Interventions:

Other: Standard care (eg. antiplatelet drugs and statins)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Xingnaojing injection

Xingnaojing injection 20 ml+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 7 days.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital

UNKNOWN

Sponsor Role: collaborator

Ying Gao

OTHER

Sponsor Role: lead

Responsible Party

Ying Gao

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gao

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital

Locations

Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Qin

Role: CONTACT

qinmz@bucm.edu.cn

17801222857

Facility Contacts

Qiu

Role: primary

18182538201

Other Identifiers

2018YFC1705001-05-02

Identifier Type: -

Identifier Source: org_study_id