Taking people in ChinaPhase 3
Tests Shuxuening Injection added to clot-dissolving treatment for acute ischemic stroke
Tests Shuxuening Injection alongside clot-dissolving drugs in people with acute ischemic stroke.
Key facts
- Who runs it
- Beijing Tiantan Hospital
- Where
- Anshan, Anyang, Baoding, Baotou, Beijing, Benxi, Changsha, Chenzhou, Chongqing, Dalian, Dandong, Dezhou, Guangzhou, Harbin, Heyuan, Heze, Hinggan, Hohhot, Huai'an, Hulunbuir, Jiaozuo, Jinan, Jincheng, Jingmen, Jingzhou, Jinzhong, Jinzhou, Jiyuan, Kaifeng, Kunming, Liaocheng, Linfen, Linyi, Luohe, Luoyang, Maoming, Meizhou, Nanning, Pingdingshan, Puyang, Qianjiang, Qinhuangdao, Sanmenxia, Shangqiu, Shaoyang, Shenyang, Shihezi, Tianjin, Weihai, Wuhan, Xi’an, Xinxiang, Yan’an, Yantai, Yunfu, Zhanjiang, Zhongshan, Zhuhai, Zibo, and Zunyi, ChinaSee the 82 sites
- Trial code
- Registry title
- Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,380 people, planned
- Started
- 11 Jan 2024
- Planned end
- 31 Jul 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Shuxuening Injection
- Placebo
- Record updated
- 24 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a new ischemic stroke who have had or will have clot-dissolving treatment through a vein. It tests Shuxuening injection against a placebo.
- Age
- 18 to 100 years
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke, within 6 hours of onset, with an NIHSS score of 4 to 25 points at enrollment.
- Earlier treatment
- Must have received or plan to receive intravenous thrombolytic therapy. Cannot have taken neuroprotective agents such as edaravone after the onset.
Main reasons for not taking part
- mRS score greater than 1 point before the stroke
- Bleeding or other brain disorders seen on CT/MRI
- History of clotting disorders, systemic bleeding, thrombocytopenia or neutropenia
- Severe liver or kidney problems
- Allergy to Shuxuening injection or ginkgo biloba products
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Allergic to Shuxuening injection or preparations containing ginkgo biloba (ginkgo biloba extract)
- 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)
- Women who are pregnant or breastfeeding, and women of childbearing age who have a negative pregnancy test but refuse to take effective contraceptive measures
- mRS score greater than 1 point before the onset
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Where in China
- Haicheng Hospital of Traditional Chinese MedicineAnshan, ChinaContact: Shiqi WenTaking people
- Puyang Anyang District HospitalAnyang, ChinaContact: Jianzhong DengTaking people
- Baoding Xushui District People's HospitalBaoding, ChinaContact: Zhiguo LiuTaking people
- The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyBaotou, ChinaContact: Lie WuTaking people
- Fangshan District First HospitalBeijing, ChinaContact: Jianhua LiTaking people
- Benxi Central HospitalBenxi, ChinaContact: Chengguang SongTaking people
- Liuyang Jili HospitalChangsha, ChinaContact: Yuzhang BeiTaking people
- Chenzhou First People's HospitalChenzhou, ChinaContact: Xiaoxi YaoTaking people
- Chongqing Nanchuan District People's HospitalChongqing, ChinaContact: Li ChenTaking people
- Chongqing Sanbo Chang 'an HospitalChongqing, ChinaContact: Xianwen HanTaking people
- Xinhua Hospital Affiliated to Dalian UniversityDalian, ChinaContact: Haitao ChiTaking people
- Dandong Central HospitalDandong, ChinaContact: Ming SunTaking people
- Ningjin People's HospitalDezhou, ChinaContact: Chunjie YangTaking people
- The First Affiliated Hospital of Guangdong Pharmaceutical UniversityGuangzhou, ChinaContact: Aiqun ZhaoTaking people
- The Second Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaContact: Lihua WangTaking people
- Wuchang Hospital of Traditional Chinese MedicineHarbin, ChinaContact: Yuequn FangTaking people
- Heyuan People's HospitalHeyuan, ChinaContact: Jinzhao HeTaking people
- Yuncheng People's HospitalHeze, ChinaContact: Guoqiang YangTaking people
- Tuquan People's HospitalHinggan, ChinaContact: Ying HanTaking people
- Inner Mongolia Hangtian HospitalHohhot, ChinaContact: Haichao LiuTaking people
- Huai'an Second People's HospitalHuai'an, ChinaContact: Xiangyang CaoTaking people
- Zalantun Zhongmeng HospitalHulunbuir, ChinaContact: Chengyan YangTaking people
- Zhalantun People's HospitalHulunbuir, ChinaContact: Chengyan YangTaking people
- Jiaozuo Coal Industry (Group) Co. Ltd. Central HospitalJiaozuo, ChinaContact: Bosheng FanTaking people
- Mengzhou Hospital of Traditional Chinese MedicineJiaozuo, ChinaContact: Baoguo XueTaking people
- Wenxian People's HospitalJiaozuo, ChinaContact: Xiaoyu WangTaking people
- Shandong Provincial Public Health Clinical CenterJinan, ChinaContact: Qinghua ZhangTaking people
- Jincheng People's HospitalJincheng, ChinaContact: Lina XuTaking people
- Jingmen Hospital of Traditional Chinese MedicineJingmen, ChinaContact: Ming ZhangTaking people
- Jingzhou First People's HospitalJingzhou, ChinaContact: Qiang TuTaking people
- Yuci District People's HospitalJinzhong, ChinaContact: Aishe ZhaoTaking people
- The First Affiliated Hospital of Jinzhou Medical UniversityJinzhou, ChinaContact: Fang LiTaking people
- Jiyuan Hospital of Traditional Chinese MedicineJiyuan, ChinaContact: Hongqin YangTaking people
- Kaifeng Central HospitalKaifeng, ChinaContact: Xinsheng HanTaking people
- Lankao First HospitalKaifeng, ChinaContact: Jianguo DongTaking people
- Yunnan Third People's HospitalKunming, ChinaContact: Wei HuangTaking people
- Guanxian People's HospitalLiaocheng, ChinaContact: Haijun QiuTaking people
- Liaocheng Third People's HospitalLiaocheng, ChinaContact: Liguo ChangTaking people
- Linfen Central HospitalLinfen, ChinaContact: Hongguo DaiTaking people
- Linfen People's HospitalLinfen, ChinaContact: Wenji JingTaking people
- Linshu People's HospitalLinyi, ChinaContact: Shoujun MaTaking people
- Luohe Third People's HospitalLuohe, ChinaContact: Huimin LiTaking people
- Luoyang Yanshi People's HospitalLuoyang, ChinaContact: Yang ZhouTaking people
- Huazhou People's HospitalMaoming, ChinaContact: Zhiyi WangTaking people
- Meizhou Hospital of Traditional Chinese MedicineMeizhou, ChinaContact: Miaoquan LuoTaking people
- Wuming Hospital Affiliated to Guangxi Medical CollegeNanning, ChinaContact: Xisi MengTaking people
- Pingdingshan First People's HospitalPingdingshan, ChinaContact: Enhui GuoTaking people
- Pingdingshan Second People's HospitalPingdingshan, ChinaContact: Yankuo WangTaking people
- Nanle Zhongxing HospitalPuyang, ChinaContact: Yungao PanTaking people
- Chongqing Qianjiang Central HospitalQianjiang, ChinaContact: Xiaoping XiongTaking people
- Qinhuangdao Second HospitalQinhuangdao, ChinaContact: Guanglei LiTaking people
- Lingbao First People's HospitalSanmenxia, ChinaContact: Wei WuTaking people
- Shangqiu First People's HospitalShangqiu, ChinaContact: Liang ZhangTaking people
- Shangqiu Fourth People's HospitalShangqiu, ChinaContact: Haichao LiuTaking people
- Shangqiu Third Prople's HospitalShangqiu, ChinaContact: Yong LiuTaking people
- Suixian Hospital of Traditional Chinese MedicineShangqiu, ChinaContact: Ying LiTaking people
- Suixian People's HospitalShangqiu, ChinaContact: Yunchao ChenTaking people
- Xiayi People's HospitalShangqiu, ChinaContact: Xiaoguang SongTaking people
- Yongcheng Central HospitalShangqiu, ChinaContact: Can JiangTaking people
- Yongcheng People's HospitalShangqiu, ChinaContact: Fengqin LiTaking people
- Shaodong People's HospitalShaoyang, ChinaContact: Lingyan DengTaking people
- Shenyang First People's HospitalShenyang, ChinaContact: Yi SuiTaking people
- The First Affiliated Hospital of Shihezi University Medical CollegeShihezi, ChinaContact: Juan YuTaking people
- Tianjin Xiqing HospitalTianjin, ChinaContact: Yuqing HanTaking people
- Weihai Wendeng District People' HospitalWeihai, ChinaContact: Jinguo ZhaoTaking people
- Wuhan Central HospitalWuhan, ChinaContact: Ping JingTaking people
- Wuhan Fifth HospitalWuhan, ChinaContact: Xiliu ZhangTaking people
- Wuhan Hankou HospitalWuhan, ChinaContact: Wenyong GaoTaking people
- Wuhan Huangpi District People's HospitalWuhan, ChinaContact: Jing LiTaking people
- Zhongnan Hospital of Wuhan UniversityWuhan, ChinaContact: Bin MeiTaking people
- The First Affiliated Hospital of Xi'an Jiao Tong UniversityXi’an, ChinaContact: Qiuwu LiuTaking people
- Huixian People's HospitalXinxiang, ChinaContact: Weiyi GouTaking people
- The First Affiliated Hospital of Xinxiang Medical UniversityXinxiang, ChinaContact: Jianhua ZhaoTaking people
- Yan'an University Affiliated HospitalYan’an, ChinaContact: Yidong XueTaking people
- Yantai Yeda HospitalYantai, ChinaContact: Mingqing ZhenTaking people
- Yunfu People's HospitalYunfu, ChinaContact: Yuanbing HuangTaking people
- Wuchuan People's HospitalZhanjiang, ChinaContact: Guanrong ChenTaking people
- Zhongshan People's HospitalZhongshan, ChinaContact: Fuyuan HuoTaking people
- The Fifth Affiliated Hospital of Sun Yat-sen UniversityZhuhai, ChinaContact: Lei ZhangTaking people
- Zibo Municipal HospitalZibo, ChinaContact: Zengqiang SunTaking people
- Wuchuan Gelao and Miao Autonomous County Hospital of Traditional Chinese MedicineZunyi, ChinaContact: Xiaojiang GuanTaking people
- Zunyi First People's HospitalZunyi, ChinaContact: Xiaohong FuTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Shuxuening injectionTreatment being tested
Shuxuening Injection + Intravenous Thrombolysis
- PlaceboPlacebo, for comparison
Placebo + Intravenous Thrombolysis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests Shuxuening Injection added to clot-dissolving treatment for acute ischemic strokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06157502, who can take part
- Publications
- Record updated
- 24 July 2025