Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1200 participants
INTERVENTIONAL
2020-03-19
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Xingnaojing
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Xingnaojing injection
Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.
Standard care
Guidelines-based standard care for acute ischemic stroke.
Placebo
Subjects will receive intravenously administered Xingnaojing placebo, combined with guidelines-based standard care.
Xingnaojing placebo injection
Xingnaojing placebo injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.
Standard care
Guidelines-based standard care for acute ischemic stroke.
Interventions
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Xingnaojing injection
Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.
Xingnaojing placebo injection
Xingnaojing placebo injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.
Standard care
Guidelines-based standard care for acute ischemic stroke.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
80 Years
ALL
No
Sponsors
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Peking University Third Hospital
OTHER
Beijing Shuyi Hospital
OTHER
The Airport Hospital of Shunyi District Beijing
UNKNOWN
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
OTHER
The NO.4 People's Hospital of Hengshui
UNKNOWN
The Second Hospital of Hebei Medical University
OTHER
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
OTHER
The Affiliated Hospital of Shaanxi University of Chinese Medicine
UNKNOWN
Tianshui Hospital of Traditional Chinese Medicine
UNKNOWN
The Affiliated Hospital of Changzhi Academy of TCM
UNKNOWN
Zibo Hospital of Traditional Chinese Medicine
OTHER
Yantai Yuhuangding Hospital
OTHER
Shandong University of Traditional Chinese Medicine
OTHER
Zhejiang Provincial Hospital of TCM
OTHER
Zhejiang Provincial Tongde Hospital
OTHER
Second Affiliated Hospital of Wenzhou Medical University
OTHER
People's Hospital of Quzhou
OTHER
Longhua Hospital
OTHER
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
OTHER
Taizhou Hospital of Traditional Chinese Medicine
OTHER_GOV
The First Affiliated Hospital of Guizhou University of TCM
UNKNOWN
Guangzhou Hospital of Traditional Chinese Medicine
UNKNOWN
The First Affiliated Hospital of Guangxi University of Chinese Medicine
UNKNOWN
Liling Hospital of Traditional Chinese Medicine
UNKNOWN
Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
UNKNOWN
Hubei Hospital of Traditional Chinese Medicine
OTHER
The First Hospital of Jilin University
OTHER
Anshan Central Hospital
OTHER
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
OTHER
The First Hospital of Qiqihar City
UNKNOWN
Haikou People's Hospital
OTHER
The Second People's Hospital of Anhui Province
OTHER
The Third Affiliated Hospital of Shenzhen University
UNKNOWN
The Third People's Hospital of Hubei Province
OTHER
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
OTHER
The Third Hospital of Xi'an City
UNKNOWN
Dongzhimen Hospital, Beijing
OTHER
Responsible Party
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Ying Gao
President of the Institute for Encephalopathy, Beijing University of Chinese Medicine
Principal Investigators
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Ying Gao, MD
Role: PRINCIPAL_INVESTIGATOR
Dongzhimen Hospital
Locations
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Dongzhimen Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018YFC1705001
Identifier Type: -
Identifier Source: org_study_id
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