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

NCT ID: NCT04813445

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-28
• Study Completion Date: 2022-09-28

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.

Conditions

Acute Stroke; Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Xingnaojing injection

Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.

Interventions:

Drug: Xingnaojing injection Other: Standard care

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 10 days.

Standard care

Subjects will receive guidelines-based standard care.

Interventions:

Other: Standard care

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 10 days.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: collaborator

Nanjing Brian Hospital

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Chengde Medical University

OTHER

Sponsor Role: collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Ying Gao

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dongzhimen Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ying Gao, MD

Role: primary

gaoying973@126.com

0086-010-84013209

Ping Jiang, MD

Role: backup

18810923089@163.com

0086-18810923089

Other Identifiers

2018YFC1705001-05

Identifier Type: -

Identifier Source: org_study_id