Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)
Efficacy and Safety of Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial
1 other identifier
interventional
1,380
1 country
82
Brief Summary
Shuxuening injection is a multi-target neuroprotective agent, it is expected to play a neuroprotective role on the basis of intravenous thrombolysis therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of Shuxuening injection in the treatment with intravenous thrombolysis in patients with ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2024
Typical duration for phase_3
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2023
CompletedFirst Posted
Study publicly available on registry
December 5, 2023
CompletedStudy Start
First participant enrolled
January 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
ExpectedJuly 24, 2025
July 1, 2025
2 years
November 27, 2023
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of mRS score 0 to 1 at 90 days after randomization
The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.
At 90 days after randomization
Secondary Outcomes (10)
The proportion of mRS score 0 to 2 at 90 days after randomization
At 90 days after randomization
The distribution of mRS scores at 90 days after randomization
At 90 days after randomization
NIHSS score improvement ≥4 points from baseline at 14 days after randomization or on discharge
At 14 days after randomization or on discharge
EQ-5D score at 90 days after randomization
At 90 days after randomization
The proportion of Barthel index score ≥95 points at 90 days after randomization
At 90 days after randomization
- +5 more secondary outcomes
Study Arms (2)
Shuxuening injection
EXPERIMENTALShuxuening Injection + Intravenous Thrombolysis
Placebo
PLACEBO COMPARATORPlacebo + Intravenous Thrombolysis
Interventions
Receiving 20 ml Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days
Receiving 20 ml placebo Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days.
Eligibility Criteria
You may qualify if:
- Age 18 or older;
- Diagnosed with acute ischemic stroke;
- Within 6 hours of onset;
- Having received or plan to undergo intravenous thrombolytic therapy;
- NIHISS score of 4 to 25 points at enrollment;
- Signed informed consent.
You may not qualify if:
- mRS score greater than 1 point before the onset;
- Receiving neuroprotective agents, such as edaravone, edaravone dextrocamphorol, butylphthalein, etc. after the onset;
- Bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis), detected by CT/MRI;
- History of clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia;
- Severe hepatic or renal insufficiency (severe hepatic insufficiency refers to the ALT or AST levels above 3 times the upper limit of normal; severe renal insufficiency refers to the creatinine levels above 2 times the upper limit of normal);
- Allergic to Shuxuening injection or preparations containing ginkgo biloba (ginkgo biloba extract);
- Women who are pregnant or breastfeeding, and women of childbearing age who have a negative pregnancy test but refuse to take effective contraceptive measures;
- Participation in another clinical trial with an experimental product during the last 30 days;
- Other participants deemed unsuitable for participation in this study by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
Fangshan District First Hospital
Beijing, Beijing Municipality, China
Chongqing Nanchuan District People's Hospital
Chongqing, Chongqing Municipality, China
Chongqing Sanbo Chang'an Hospital
Chongqing, Chongqing Municipality, China
Chongqing Qianjiang Central Hospital
Qianjiang, Chongqing Municipality, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Heyuan People's Hospital
Heyuan, Guangdong, China
Huazhou People's Hospital
Maoming, Guangdong, China
Meizhou Hospital of Traditional Chinese Medicine
Meizhou, Guangdong, China
Yunfu People's Hospital
Yunfu, Guangdong, China
Wuchuan People's Hospital
Zhanjiang, Guangdong, China
Zhongshan People's Hospital
Zhongshan, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Wuming Hospital Affiliated to Guangxi Medical College
Nanning, Guangxi, China
Wuchuan Gelao and Miao Autonomous County Hospital of Traditional Chinese Medicine
Zunyi, Guizhou, China
Zunyi First People's Hospital
Zunyi, Guizhou, China
Baoding Xushui District People's Hospital
Baoding, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Wuchang Hospital of Traditional Chinese Medicine
Harbin, Heilongjiang, China
Puyang Anyang District Hospital
Anyang, Henan, China
Jiaozuo Coal Industry (Group) Co. Ltd. Central Hospital
Jiaozuo, Henan, China
Mengzhou Hospital of Traditional Chinese Medicine
Jiaozuo, Henan, China
Wenxian People's Hospital
Jiaozuo, Henan, China
Jiyuan Hospital of Traditional Chinese Medicine
Jiyuan, Henan, China
Kaifeng Central Hospital
Kaifeng, Henan, China
Lankao First Hospital
Kaifeng, Henan, China
Luohe Third People's Hospital
Luohe, Henan, China
Luoyang Yanshi People's Hospital
Luoyang, Henan, China
Pingdingshan First People's Hospital
Pingdingshan, Henan, China
Pingdingshan Second People's Hospital
Pingdingshan, Henan, China
Nanle Zhongxing Hospital
Puyang, Henan, China
Qinhuangdao Second Hospital
Qinhuangdao, Henan, China
Lingbao First People's Hospital
Sanmenxia, Henan, China
Shangqiu First People's Hospital
Shangqiu, Henan, China
Shangqiu Fourth People's Hospital
Shangqiu, Henan, China
Shangqiu Third Prople's Hospital
Shangqiu, Henan, China
Suixian Hospital of Traditional Chinese Medicine
Shangqiu, Henan, China
Suixian People's Hospital
Shangqiu, Henan, China
Xiayi People's Hospital
Shangqiu, Henan, China
Yongcheng Central Hospital
Shangqiu, Henan, China
Yongcheng People's Hospital
Shangqiu, Henan, China
Huixian People's Hospital
Xinxiang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Jingmen Hospital of Traditional Chinese Medicine
Jingmen, Hubei, China
Jingzhou First People's Hospital
Jingzhou, Hubei, China
Wuhan Central Hospital
Wuhan, Hubei, China
Wuhan Fifth Hospital
Wuhan, Hubei, China
Wuhan Hankou Hospital
Wuhan, Hubei, China
Wuhan Huangpi District People's Hospital
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Liuyang Jili Hospital
Changsha, Hunan, China
Chenzhou First People's Hospital
Chenzhou, Hunan, China
Shaodong People's Hospital
Shaoyang, Hunan, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, China
Tuquan People's Hospital
Hinggan, Inner Mongolia, China
Inner Mongolia Hangtian Hospital
Hohhot, Inner Mongolia, China
Zalantun Zhongmeng Hospital
Hulunbuir, Inner Mongolia, China
Zhalantun People's Hospital
Hulunbuir, Inner Mongolia, China
Huai'an Second People's Hospital
Huai'an, Jiangsu, China
Haicheng Hospital of Traditional Chinese Medicine
Anshan, Liaoning, China
Benxi Central Hospital
Benxi, Liaoning, China
Xinhua Hospital Affiliated to Dalian University
Dalian, Liaoning, China
Dandong Central Hospital
Dandong, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Shenyang First People's Hospital
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China
Yan'an University Affiliated Hospital
Yan’an, Shaanxi, China
Ningjin People's Hospital
Dezhou, Shandong, China
Yuncheng People's Hospital
Heze, Shandong, China
Shandong Provincial Public Health Clinical Center
Jinan, Shandong, China
Guanxian People's Hospital
Liaocheng, Shandong, China
Linshu People's Hospital
Linyi, Shandong, China
Liaocheng Third People's Hospital
Liaocheng, Shangdong, China
Weihai Wendeng District People' Hospital
Weihai, Shangdong, China
Yantai Yeda Hospital
Yantai, Shangdong, China
Zibo Municipal Hospital
Zibo, Shangdong, China
Jincheng People's Hospital
Jincheng, Shanxi, China
Yuci District People's Hospital
Jinzhong, Shanxi, China
Linfen Central Hospital
Linfen, Shanxi, China
Linfen People's Hospital
Linfen, Shanxi, China
Tianjin Xiqing Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Shihezi University Medical College
Shihezi, Xinjiang, China
Yunnan Third People's Hospital
Kunming, Yunnan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President
Study Record Dates
First Submitted
November 27, 2023
First Posted
December 5, 2023
Study Start
January 11, 2024
Primary Completion
December 31, 2025
Study Completion (Estimated)
July 31, 2026
Last Updated
July 24, 2025
Record last verified: 2025-07