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

NCT04813445 | Unknown

• 1 other identifier: 2018YFC1705001-05
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The change of NIHSS score

  The NIHSS score ranges from 0 (best score) to 42 (worst score).

  Baseline, 3 days, 7 days and 10 days

Secondary Outcomes (9)

• The proportion of NIHSS score from 0 to 1

  Baseline, 3 days, 7 days and 10 days

• Patient reported outcome (PRO) scale of stroke

  10 days

• The proportion of patients independent at 30 days and 90 days

  30 days and 90 days

• Cardio-cerebral vascular incident

  Within baseline and 90 days

• The difference in proteomic and metabolomics

  baseline (pre-dose), 7 days and 11days

Study Arms (2)

Xingnaojing injection

EXPERIMENTAL

Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Interventions: Drug: Xingnaojing injection Other: Standard care

Drug: Xingnaojing injection

Standard care

NO INTERVENTION

Subjects will receive guidelines-based standard care. Interventions: Other: Standard care

Interventions

Xingnaojing injection DRUG

Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.

Xingnaojing injection

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• 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:

• 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.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead
• Affiliated Hospital of Nantong University: collaborator
• Nanjing Brian Hospital: collaborator
• Affiliated Hospital of Chengde Medical University: collaborator

Study Sites (1)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

xingnaojing

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 24, 2021
• Study Start: May 28, 2021
• Primary Completion: June 28, 2022
• Study Completion: September 28, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)