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;