Overview

Xingnaojing for Mild-to-severe Acute Ischemic Stroke

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dongzhimen Hospital, Beijing
Collaborators:
Anshan Central Hospital
Beijing Shuyi Hospital
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
First Hospital of Jilin University
Guangzhou Hospital of Traditional Chinese Medicine
Haikou People's Hospital
Hubei Hospital of Traditional Chinese Medicine
Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
Liling Hospital of Traditional Chinese Medicine
Longhua Hospital
Peking University Third Hospital
People's Hospital of Quzhou
Second Affiliated Hospital of Wenzhou Medical University
Shandong University of Traditional Chinese Medicine
Taizhou Hospital of Traditional Chinese Medicine
The Affiliated Hospital of Changzhi Academy of TCM
The Affiliated Hospital of Liaoning University of TCM
The Affiliated Hospital of Shaanxi University of Chinese Medicine
The Airport Hospital of Shunyi District Beijing
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
The First Affiliated Hospital of Guangxi University of Chinese Medicine
The First Affiliated Hospital of Guizhou University of TCM
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
The First Hospital of Jilin University
The First Hospital of Qiqihar City
The NO.4 People's Hospital of Hengshui
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
The Second Hospital of Hebei Medical University
The Second People's Hospital of Anhui Province
The Third Affiliated Hospital of Shenzhen University
The Third Hospital of Xi'an City
The third people's Hospital of Hubei Province
Tianshui Hospital of Traditional Chinese Medicine
Yantai Yuhuangding Hospital
Zhejiang Provincial Hospital of TCM
Zhejiang Provincial Tongde Hospital
Zibo Hospital of Traditional Chinese Medicine
Criteria
Inclusion Criteria:

- 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.

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;

- Currently receiving an investigational drug;