Danhong Injection in the Treatment of Acute Ischemic Stroke
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ClinicalTrials.gov Identifier: NCT01677208 |
Recruitment Status
:
Recruiting
First Posted
: August 31, 2012
Last Update Posted
: January 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Stroke | Drug: Danhong injection Procedure: Standard medical care Drug: placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1513 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Acute Ischemic Stroke |
Study Start Date : | December 2012 |
Estimated Primary Completion Date : | June 2019 |
Estimated Study Completion Date : | June 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Danhong injection
Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
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Drug: Danhong injection
A kind of injection made from two kind of Chinese herbs: Salvia miltiorrhiza and Safflower. 40ml Danhong injection added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion
Procedure: Standard medical care
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.
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Placebo Comparator: placebo
Based on the standard medical care, 40ml of 0.9% saline as the placebo, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
|
Procedure: Standard medical care
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.
Drug: placebo
0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
|
- Modified Rankin Scale 0-1 (favourable outcome) at Day 90 [ Time Frame: Day 90 ]
- The Score of effect on symptoms of "Xueyue Zheng"(Blood Stasis syndrome) [ Time Frame: Day 0, Day7, Day 14, Day 30, Day 60, Day 90 ]
- Barthel Index score ≥90 [ Time Frame: Day 0, Day7, Day 14, Day 30, Day 60, Day 90 ]
- NIH stroke scale(NIHSS) [ Time Frame: Day 0, Day7, Day 14, Day 30, Day 60, Day 90 ]The improvement of the NIHSS score ≥4 or the NIHSS score of 0 to 1
- EQ-5D scale [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ]
- Global disability on mRS at Day 90. [ Time Frame: Day 90 ]The proportion of patients with mRS ≥3 at Day 90.
- Incidence of new-onset major vascular events in 90 days [ Time Frame: Day 90 ]Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
- Overall mortality at day 90 [ Time Frame: Day 90 ]
- Incidence of severe hemorrhages in 90 days [ Time Frame: Day 90 ]The definition of "Severe hemorrhages" is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment.
- Incidence of moderate hemorrhages in 90 days [ Time Frame: Day 90 ]The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.
- Documentation of adverse events (AEs) and serious AEs [ Time Frame: 90 days ]
- The changes on the profiles of micro-RNA in 96 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ]
- The changes on the expression profiles of mRNA in 96 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female or male inpatients
- Age: 18 - 70 years.
- Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes hemorrhage.
- Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in ischemic stroke ≥ 20. The Chinese medicine symptoms scales of "Xueyu Zheng" is defined as following (1)hemiplegia-10,(2)numbness of limbs-10,(3) dark face-9,(4)purple or dark lip-8,(5)Roughness of skin-4, (6) pain with fixed point-5, (7) purple or dark tongue-10,(8)ecchymosis on tongue-10,(9)purple sublingual vessel-10,(10)varicose sublingual vessel-8,(11)unsmooth pulse-8,(12)intermittent pulse-1.
- Onset of symptoms in 1 week prior to initiation of administration of study drug.
- Clinical diagnosis of cerebral anterior circulation obstruction.
- 4≤NIHSS<20.
- Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating centers.
Exclusion Criteria:
- Evidence of intracranial hemorrhage (ICH) or other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.)on the CT-or MRI-scan.
- Patients with thrombolysis or endovascular treatment.
- Known history of allergy or suspected allergic to the drug.
- Blood glucose 2.8 or > 16.8 mmol / l under the treatment of diabetes or with severe complications due to diabetes (eg. peripheral neuropathy, diabetic gangrene).
- Liver function impairment with the value of ALT or AST over 1.5-fold of normal value.
- Renal dysfunction with the value of serum creatinine over 1.5-fold of normal value.
- Severe cardiac dysfunction on echocardiogram or the grade of heart function over Ⅲ grade.
- History of prior stroke with mRS ≥2.
- Complicated with atrial fibrillation.
- Severe stroke as assessed by appropriate imaging techniques (eg. massive cerebral infarction including more than one lobe of brain or over 1/3 of blood-supply area of middle cerebral artery).
- Prior disable patients.
- Hemorrhagic tendency or recent severe or dangerous bleeding in 3 months.
- Suspected addicted into alcohol or drug abuse.
- With severe complications that would make the condition more complicated assessed by the investigator.
- Woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent 6 months.
- Woman who is under menstrual period.
- Patient who is participating in other trials or has been participated in other trials in recent 3 months.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677208
Contact: Zhong Wang, Professor | 8610-64014411 ext 3308 | zhonw@vip.sina.com | |
Contact: Jun Liu, Ph.D. | 8610-64014411 ext 2805 | franlj1104@aliyun.com |

China, Beijing | |
The Second Artillery General Hospital of Chinese People's Liberation Army | Completed |
Beijing, Beijing, China, 100088 | |
China, Chongqing | |
Xinqiao Hospital of Third Military Medical University | Recruiting |
Chongqing, Chongqing, China, 400037 | |
Contact: Qing-wu Yang, M.D. | |
Principal Investigator: Qing-wu Yang, M.D. | |
Chongqing Three Gorges Central Hospital | Recruiting |
Chongqing, Chongqing, China, 404000 | |
Contact: Shu-qiong Zhang, Professor | |
Principal Investigator: Shu-qiong Zhang, Professor | |
China, Guangdong | |
Guangdong No.2 Provincial People's Hospital | Recruiting |
Guangzhou, Guangdong, China, 510317 | |
Contact: Xin-tong Liu, M.D. | |
Principal Investigator: Xin-tong Liu, M.D. | |
Guangzhou hospital of integrated Chinese and Western medicine | Recruiting |
Guangzhou, Guangdong, China, 510813 | |
Contact: Chao-jun Chen, M.D. | |
Principal Investigator: Chao-jun Chen | |
China, Hebei | |
Affiliated Hospital of Chengde Medical University | Recruiting |
Chengde, Hebei, China, 067000 | |
Contact: Yan-jun Gao | |
Principal Investigator: Yan-jun Gao | |
Handan Central Hospital | Recruiting |
Handan, Hebei, China, 056001 | |
Contact: Jun-tao Li 86-310-2112562 | |
Principal Investigator: Jun-tao Li | |
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Xingtai, Hebei, China, 054099 | |
China, Henan | |
The First Affiliated Hospital of Henan University of T.C.M. | Recruiting |
Zhengzhou, Henan, China, 450000 | |
Contact: Xin-zhi Wang, Professor 86371-66201040 znqznq@163.com | |
Principal Investigator: Xin-zhi Wang, Professor | |
People's Hospital of Zhengzhou | Recruiting |
Zhengzhou, Henan, China, 450003 | |
Contact: Lai-hui Feng, Professor | |
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Zhengzhou NO.7 People's Hospital | Recruiting |
Zhengzhou, Henan, China, 450006 | |
Contact: Jun-xing Dong, Professor | |
Principal Investigator: Jun-xing Dong, Professor | |
China, Hubei | |
The Second Central Hospital of Baoding City | Recruiting |
Baoding, Hubei, China, 072750 | |
Contact: Shuang-xia Du | |
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The Central Hospital of Wuhan | Recruiting |
Wuhan, Hubei, China, 430014 | |
Contact: Lin-hong Zhang, Professor | |
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Zhongnan Hospital of Wuhan University | Recruiting |
Wuhan, Hubei, China, 430030 | |
Contact: Yu-min Liu, M.D. 8627-67813086 | |
Principal Investigator: Yu-min Liu, M.D. | |
Zhongshan Hospital of Hubei Province | Recruiting |
Wuhan, Hubei, China, 430033 | |
Contact: Xiao-rong Deng, Professor xiaorong9596@aliyun.com | |
Principal Investigator: Xiao-rong Deng, Professor | |
Fifth Hospital in Wuhan | Recruiting |
Wuhan, Hubei, China, 430050 | |
Contact: Ming Li | |
Principal Investigator: Ming Li | |
Renmin Hospital of Wuhan University | Recruiting |
Wuhan, Hubei, China, 430060 | |
Contact: Zhao-hui Zhang, M.D. 8627-88041919 ext 82143 | |
Principal Investigator: Zhao-hui Zhang, M.D. | |
Hubei Provincial Hospital of T.C.M. | Withdrawn |
Wuhan, Hubei, China, 430061 | |
Tianyou Hospital Affiliated to Wuhan University of Science & Technology | Recruiting |
Wuhan, Hubei, China, 430064 | |
Contact: Jun Peng | |
Principal Investigator: Jun Peng | |
China, Hunan | |
Changsha Central Hospital | Recruiting |
Changsha, Hunan, China, 410004 | |
Contact: Zhu-xin Liu, Professor 86-13975128927 | |
Principal Investigator: Zhu-xin Liu, Professor | |
The First Hospital of Changsha | Recruiting |
Changsha, Hunan, China, 410005 | |
Contact: Ai-min Wang, Professor wangaimindoc@163.com | |
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The second people's hospital of Hunan Province | Recruiting |
Changsha, Hunan, China, 410007 | |
Contact: Qiu-ting Liu, Professor 13974809911@163.com | |
Principal Investigator: Qiu-ting Liu, Professor | |
Xiangya Hospital Central-south University | Completed |
Changsha, Hunan, China, 410008 | |
China, Jiangsu | |
Nanjing Hospital of T.C.M. | Terminated |
Nanjing, Jiangsu, China, 210001 | |
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Nanjing, Jiangsu, China, 210003 | |
Nanjing Drum Tower Hospital | Terminated |
Nanjing, Jiangsu, China, 210008 | |
China, Jilin | |
Jilin Province People's Hospital | Recruiting |
Changchun, Jilin, China, 130021 | |
Contact: Hong-xia Sun, Professor | |
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Changchun, Jilin, China, 130021 | |
The First Hospital Affiliated to Jilin University | Recruiting |
Changchun, Jilin, China, 130021 | |
Contact: Jia-chun Feng, M.D. | |
Principal Investigator: Jia-chun Feng, M.D. | |
China-Japan Union Hospital of Jilin University | Recruiting |
Changchun, Jilin, China, 130033 | |
Contact: Hong Yang, Professor | |
Principal Investigator: Hong Yang, Professor | |
The Second Hospital of Jilin University | Terminated |
Changchun, Jilin, China, 130041 | |
Liaoyuan Traditional Chinese Medical Hospital | Recruiting |
Liaoyuan, Jilin, China, 136299 | |
Contact: Hong-wei Dai | |
Principal Investigator: Hong-wei Dai | |
China, Liaoning | |
Anshan Central Hospital | Recruiting |
Anshan, Liaoning, China, 114001 | |
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Affiliated Zhongshan Hospital of Dalian University | Recruiting |
Dalian, Liaoning, China, 116001 | |
Contact: Qiang Ma, Professor 86411-62893581 mqiang2100@yahoo.com.cn | |
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Panjin Central Hospital | Recruiting |
Panjin, Liaoning, China, 124013 | |
Contact: Yan-hua Zhou | |
Principal Investigator: Yan Hua | |
People's Liberation Army No.202 Hospital | Recruiting |
Shenyang, Liaoning, China, 110003 | |
Contact: Zhi-lin Jiang, Professor | |
Principal Investigator: Zhi-lin Jiang, Professor | |
The General Hospital of Shenyang Military | Recruiting |
Shenyang, Liaoning, China, 110016 | |
Contact: Hui-sheng Chen, M.D. | |
Principal Investigator: Hui-sheng Chen, M.D. | |
The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | Withdrawn |
Shenyang, Liaoning, China, 110034 | |
People's Liberation Army No.463 Hospital | Recruiting |
Shenyang, Liaoning, China, 110046 | |
Contact: Shu-hang Feng, M.D. | |
Principal Investigator: Shu-hang Feng, M.D. | |
China, Neimenggu | |
Affiliated Hospital of Chifeng University | Recruiting |
Chifeng, Neimenggu, China, 024005 | |
Contact: Wei-li Zhao | |
Principal Investigator: Wei-li Zhao | |
China, Shanghai | |
Xuhui District Central Hospital of Shanghai City | Withdrawn |
Shanghai, Shanghai, China, 200031 | |
The Sixth People's Hospital of Shanghai City | Withdrawn |
Shanghai, Shanghai, China, 200233 | |
China, Shanxi | |
Fenyang Hospital of Shanxi Province | Recruiting |
Lvliang, Shanxi, China, 032299 | |
Contact: Bao-ai Wang | |
Principal Investigator: Bao-ai Wang | |
The Second Affiliated Hospital to Shanxi Medical University | Recruiting |
Taiyuan, Shanxi, China, 030001 | |
Contact: Guang-lai Li, Professor 86-13703587193 | |
Principal Investigator: Guang-lai Li, Professor | |
Shanxi Province Hospital of T.C.M. | Terminated |
Xi'an, Shanxi, China, 710003 | |
The PLA Fourth Fifty-one Hospital | Recruiting |
Xi'an, Shanxi, China, 710054 | |
Contact: Li-yi Chi, Professor 1173319088@qq.com | |
Principal Investigator: Li-yi Chi, Professor | |
Shanxi Provincial People's Hospital | Recruiting |
Xi'an, Shanxi, China, 710068 | |
Contact: Qian Yang, Professor YangQdoctor@163.com | |
Principal Investigator: Qian Yang, Professor | |
Affiliated Hospital of Shanxi University of Chinese Medicine | Recruiting |
Xianyang, Shanxi, China, 712000 | |
Contact: Yong-mei Yan, Professor 86-13609216551 | |
Principal Investigator: Yong-mei Yan, Professor | |
The Second Affiliated Hospital of Shanxi University of T.C.M. | Recruiting |
Xianyang, Shanxi, China, 712000 | |
Contact: Ju-mei Du | |
Principal Investigator: Ju-mei Du | |
China, Sichuan | |
Teaching Hospital of Chengdu University of Traditional Chinese Medicine | Recruiting |
Chengdu, Sichuan, China, 610072 | |
Contact: Yun Lu luyun999@126.com | |
Principal Investigator: Yun Lu | |
China, Tianjin | |
Tianjin Medical University General Hospital | Active, not recruiting |
Tianjin, Tianjin, China, 300052 | |
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Recruiting |
Tianjin, Tianjin, China, 300193 | |
Contact: Zhi-hong Meng, M.D. 86-18722699933 | |
Principal Investigator: Zhi-hong Meng, M.D. | |
China, Zhejiang | |
The First Affiliated Hospital of College of Medicine, Zhejiang University | Withdrawn |
Hangzhou, Zhejiang, China, 310003 | |
Xin Hua Hospital of Zhejiang Province | Recruiting |
Hangzhou, Zhejiang, China, 310005 | |
Contact: Bin Xu, Professor 86-571-85288221 | |
Principal Investigator: Bin Xu, Professor | |
Zhejiang Provincial Hospital of T.C.M. | Recruiting |
Hangzhou, Zhejiang, China, 310006 | |
Contact: Qun Hou, Professor houqun168@163.com | |
Principal Investigator: Qun Hou, Professor | |
Zhejiang Provincial People's Hospital | Recruiting |
Hangzhou, Zhejiang, China, 310014 | |
Contact: Yu Geng, M.D. gengy2004@126.com | |
Principal Investigator: Yu Geng, M.D. | |
Huzhou Central Hospital | Active, not recruiting |
Huzhou, Zhejiang, China, 313003 | |
China | |
Peking University First Hospital | Terminated |
Beijing, China, 100034 | |
Peking University of People's Hospital | Withdrawn |
Beijing, China, 100044 | |
Tiantan Hospital Affiliated to Capital Medical University | Recruiting |
Beijing, China, 100050 | |
Contact: Xing-quan Zhao, M.D. 010-67098891 zxq@vip.163.com | |
Principal Investigator: Xing-quan Zhao, M.D. | |
Xuan Wu Hospital Affiliated to Capital Medical University | Recruiting |
Beijing, China, 100053 | |
Contact: Li Gao, Professor 8610-83198728 xuanwugaoli@126.com | |
Principal Investigator: Li Gao, Professor |
Principal Investigator: | Zhong Wang, Professor | Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences | |
Principal Investigator: | Xing-quan Zhao, Professor | Beijing Tiantan Hospital | |
Study Chair: | Yong-yan Wang, Professor | Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences | |
Study Director: | Xiao-xi Du, Professor | China Food and Drug Administration |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Zhong Wang, Professor, China Academy of Chinese Medical Sciences |
ClinicalTrials.gov Identifier: | NCT01677208 History of Changes |
Other Study ID Numbers: |
DH20120423 |
First Posted: | August 31, 2012 Key Record Dates |
Last Update Posted: | January 12, 2018 |
Last Verified: | January 2018 |
Keywords provided by Zhong Wang, China Academy of Chinese Medical Sciences:
Acute Ischemic Stroke Randomized Controlled Trial Traditional Chinese Medicine |
Additional relevant MeSH terms:
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |