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

NCT05559307 | Unknown Phase 4

• 1 other identifier: 2018YFC1705001-05-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke, Acute

Outcome Measures

Primary Outcomes (4)

• Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 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.

  Baseline

• Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 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.

  6 days

• Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 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.

  7 days

• Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 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.

  8 days

Secondary Outcomes (6)

• The change of neurological deficits

  Baseline, 7 days

• Patient reported outcome

  7 days

• The proportion of life dependency

  30 days, 90 days

• The degree of disability

  30 days, 90 days

• Number of participants with cerebral vascular incidents

  90 days

Study Arms (2)

Xingnaojing injection group

EXPERIMENTAL

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)

Drug: Xingnaojing injection

Standard care group

NO INTERVENTION

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

Interventions

Xingnaojing injection DRUG

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

Xingnaojing injection group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Acute ischemic stroke；
• Symptom onset within 24 hours；
• ≤ age ≤ 80 years;
• ≤ NIHSS ≤ 25；
• Patient or legally authorized representative has signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ying Gao: lead
• Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital: collaborator

Study Sites (1)

Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

xingnaojing

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gao

  Dongzhimen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qin

CONTACT

17801222857; qinmz@bucm.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: September 29, 2022
• Study Start: August 16, 2022
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)