NCT04150835

Brief Summary

The main purpose of this trial is to determine whether Xingnaojing, intravenously administered within 24 hours of symptom onset, improves the daily living ability of acute ischemic stroke at 90 days.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

March 19, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

November 1, 2019

Last Update Submit

March 29, 2021

Conditions

Acute Ischemic StrokeStroke, AcuteStroke, Ischemic

Keywords

Acute ischemic strokeXingnaojing injectionTraditional Chinese MedicineDouble-BlindRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients independent.

    Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.The Modified Rankin Scale Score ranges from 0 (best score) to 6 (worst score).

    90 days

Secondary Outcomes (9)

  • Early neurological deterioration.

    Baseline and 3 days

  • Neurological impairment evaluated by National Institute of Health Stroke Scale (NIHSS).

    Baseline and 10 days

  • Patient reported outcome

    10 days

  • State of consciousness

    48 hours and 7 days

  • Activities of daily living

    30 days and 90 days

  • +4 more secondary outcomes

Study Arms (2)

Xingnaojing

EXPERIMENTAL

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

Drug: Xingnaojing injectionOther: Standard care

Placebo

PLACEBO COMPARATOR

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

Drug: Xingnaojing placebo injectionOther: Standard care

Interventions

Xingnaojing injectionDRUG

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

Xingnaojing
Xingnaojing placebo injectionDRUG

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

Placebo
Standard careOTHER

Guidelines-based standard care for acute ischemic stroke.

PlaceboXingnaojing

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Acute ischemic stroke；
  • Symptom onset within 24 hours；
  • Age ≥ 18 and ≤ 80 years；
  • NIHSS score ≥ 4 and ≤ 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;
  • Currently receiving an investigational drug;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

xingnaojingStandard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Ying Gao, MD

    Dongzhimen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Gao, MD

CONTACT

0086-010-84013209gaoying973@126.com

Tiantian Meng, MD

CONTACT

(+86)1781217171317812171713@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of the Institute for Encephalopathy, Beijing University of Chinese Medicine

Study Record Dates

First Submitted

November 1, 2019

First Posted

November 5, 2019

Study Start

March 19, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations

CN(1)