Danhong Injection in the Treatment of Acute Ischemic Stroke

Recruiting

Phase 4 Results N/A

Update History

3 Dec '17
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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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.
Old
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.
A location was updated in Guangzhou.
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The overall status was updated to "Recruiting" at Guangdong No.2 Provincial People's Hospital.
A location was updated in Changsha.
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The overall status was updated to "Completed" at Xiangya Hospital Central-South University.
A location was updated in Nanjing.
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The overall status was updated to "Completed" at The Second Affiliated Hospital of Nanjing Medical University.
A location was updated in Shenyang.
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The overall status was updated to "Withdrawn" at The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine.
23 Mar '16
A location was updated in Beijing.
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The overall status was updated to "Completed" at The Second Artillery General Hospital of Chinese People's Liberation Army.
A location was updated in Wuhan.
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The overall status was updated to "Withdrawn" at Hubei Provincial Hospital of T.C.M..
A location was updated in Nanjing.
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The overall status was updated to "Terminated" at Nanjing Drum Tower Hospital.
A location was updated in Changchun.
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The overall status was updated to "Terminated" at The Affiliated Hopital to Changchun University of Chinese Medicine.
A location was updated in Xi'an.
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The overall status was updated to "Terminated" at Shanxi Province Hospital of T.C.M..
10 Sep '15
A location was updated in Shenyang.
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The overall status was updated to "Recruiting" at People's Liberation Army No.463 Hospital.
24 Apr '15
A location was updated in Chongqing.
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The overall status was updated to "Recruiting" at Xinqiao Hospital of Third Military Medical University.
A location was updated in Nanjing.
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The overall status was updated to "Terminated" at Nanjing Hospital of T.C.M..
3 Feb '15
A location was updated in Shanghai.
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The overall status was updated to "Withdrawn" at The Sixth People's Hospital of Shanghai City.
30 Oct '14
A location was updated in Changchun.
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The overall status was updated to "Recruiting" at China-Japan Union Hospital of Jilin University.
A location was updated in Beijing.
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The overall status was updated to "Terminated" at Peking University First Hospital.
A location was updated in Changchun.
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The overall status was updated to "Terminated" at The Affiliated Hopital to Changchun University of Chinese Medicine.
A location was updated in Hangzhou.
New
The overall status was updated to "Withdrawn" at The First Affiliated Hospital of College of Medicine, Zhejiang University.
A location was updated in Changchun.
New
The overall status was updated to "Terminated" at The Second Hospital of Jilin University.
A location was updated in Changsha.
New
The overall status was updated to "Completed" at Xiangya Hospital Central-South University.
A location was updated in Shanghai.
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The overall status was updated to "Withdrawn" at Xuhui District Central Hospital of Shanghai City.
A location was updated in Wuhan.
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The overall status was updated to "Recruiting" at Zhongshan Hospital of Hubei Province.
5 Aug '14
A location was updated in Chongqing.
New
The overall status was updated to "Recruiting" at Xinqiao Hospital of Third Military Medical University.
A location was updated in Changchun.
New
The overall status was updated to "Recruiting" at The First Hospital Affiliated to Jilin University.
23 Apr '14
A location was updated in Chongqing.
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The overall status was updated to "Recruiting" at Chongqing Three Gorges Central Hospital.
A location was updated in Wuhan.
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The overall status was updated to "Recruiting" at Zhongnan Hospital of Wuhan University.
19 Feb '14
A location was updated in Xi'an.
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The overall status was updated to "Terminated" at Shanxi Province Hospital of T.C.M..
A location was updated in Hangzhou.
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The overall status was updated to "Recruiting" at Xin Hua Hospital of Zhejiang Province.
10 Jan '14
A location was updated in Nanjing.
New
The overall status was updated to "Terminated" at Nanjing Drum Tower Hospital.
13 Dec '13
A location was updated in Wuhan.
New
The overall status was updated to "Withdrawn" at Hubei Provincial Hospital of T.C.M..
A location was updated in Changsha.
New
The overall status was updated to "Recruiting" at The second people's hospital of Hunan Province.
A location was updated in Changsha.
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The overall status was updated to "Recruiting" at Changsha Central Hospital.
A location was updated in Changsha.
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The overall status was updated to "Recruiting" at The First Hospital of Changsha.
21 Nov '13
A location was updated in Hangzhou.
New
The overall status was updated to "Recruiting" at Zhejiang Provincial Hospital of T.C.M..
14 Nov '13
A location was updated in Wuhan.
New
The overall status was updated to "Recruiting" at Zhongnan Hospital of Wuhan University.
A location was updated in Changsha.
New
The overall status was updated to "Recruiting" at The First Hospital of Changsha.
A location was updated in Chengdu.
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The overall status was updated to "Recruiting" at Teaching Hospital of Chengdu University of Traditional Chinese Medicine.
A location was updated in Hangzhou.
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The overall status was updated to "Recruiting" at Zhejiang Provincial Hospital of T.C.M..
A location was updated in Hangzhou.
New
The overall status was updated to "Recruiting" at Zhejiang Provincial People's Hospital.
A location was updated in Hangzhou.
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The overall status was updated to "Recruiting" at Xin Hua Hospital of Zhejiang Province.
A location was updated in Beijing.
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The overall status was updated to "Recruiting" at Xuan Wu Hospital Affiliated to Capital Medical University.
A location was updated in Beijing.
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The overall status was updated to "Active, not recruiting" at Peking University People's Hospital.
23 Oct '13
A location was updated in Wuhan.
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The overall status was updated to "Recruiting" at Renmin Hospital of Wuhan University.
A location was updated in Taiyuan.
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The overall status was updated to "Recruiting" at The Second Affiliated Hospital to Shanxi Medical University.
18 Oct '13
A location was updated in Nanjing.
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The overall status was updated to "Completed" at The Second Affiliated Hospital of Nanjing Medical University.
13 Sep '13
A location was updated in Xianyang.
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The overall status was updated to "Recruiting" at Affiliated Hospital of Shanxi University of Chinese Medicine.
10 Sep '13
A location was updated in Nanjing.
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The overall status was updated to "Terminated" at Nanjing Hospital of T.C.M..
6 Sep '13
A location was updated in Changsha.
New
The overall status was updated to "Completed" at Xiangya Hospital Central-South University.
23 Aug '13
A location was updated in Changsha.
New
The overall status was updated to "Recruiting" at Changsha Central Hospital.
A location was updated in Taiyuan.
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The overall status was updated to "Recruiting" at The Second Affiliated Hospital to Shanxi Medical University.
A location was updated in Xi'an.
New
The overall status was updated to "Recruiting" at The PLA Fourth Fifty-one Hospital.
A location was updated in Xianyang.
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The overall status was updated to "Recruiting" at Affiliated Hospital of Shanxi University of Chinese Medicine.
1 Aug '13
A location was updated in Nanjing.
New
The overall status was updated to "Terminated" at Nanjing Hospital of T.C.M..
A location was updated in Nanjing.
New
The overall status was updated to "Terminated" at Nanjing Drum Tower Hospital.
A location was updated in Xi'an.
New
The overall status was updated to "Terminated" at Shanxi Province Hospital of T.C.M..
A location was updated in Xi'an.
New
The overall status was updated to "Recruiting" at The PLA Fourth Fifty-one Hospital.
27 Jun '13
A location was updated in Changchun.
New
The overall status was updated to "Terminated" at The Second Hospital of Jilin University.
A location was updated in Xi'an.
New
The overall status was updated to "Recruiting" at Shanxi Provincial People's Hospital.
12 Jun '13
A location was updated in Changchun.
New
The overall status was updated to "Terminated" at The Second Hospital of Jilin University.
A location was updated in Beijing.
New
The overall status was updated to "Recruiting" at Xuan Wu Hospital Affiliated to Capital Medical University.
29 May '13
A location was updated in Tianjin.
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The overall status was updated to "Recruiting" at First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
12 Apr '13
A location was updated in Dalian.
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The overall status was updated to "Recruiting" at Affiliated Zhongshan Hospital of Dalian University.
A location was updated in Beijing.
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The overall status was updated to "Recruiting" at Tiantan Hospital Affiliated to Capital Medical University.
10 Apr '13
A location was updated in Beijing.
New
The overall status was updated to "Recruiting" at Second Artillery General Hospital of People's Liberation Army.
6 Apr '13
A location was updated in Beijing.
New
The overall status was updated to "Terminated" at Peking University First Hospital.
30 Mar '13
A location was updated in Tianjin.
New
The overall status was updated to "Recruiting" at First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
16 Mar '13
A location was updated in Zhengzhou.
New
The overall status was updated to "Recruiting" at The First Affiliated Hospital of Henan University of T.C.M..
A location was updated in Wuhan.
New
The overall status was updated to "Recruiting" at Renmin Hospital of Wuhan University.
A location was updated in Wuhan.
New
The overall status was updated to "Recruiting" at Zhongnan Hospital of Wuhan University.
A location was updated in Changsha.
New
The overall status was updated to "Completed" at Xiangya Hospital Central-South University.
A location was updated in Changchun.
New
The overall status was updated to "Terminated" at The Second Hospital of Jilin University.
A location was updated in Dalian.
New
The overall status was updated to "Recruiting" at Affiliated Zhongshan Hospital of Dalian University.
A location was updated in Tianjin.
New
The overall status was updated to "Recruiting" at First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
A location was updated in Beijing.
New
The overall status was updated to "Active, not recruiting" at Peking University People's Hospital.
A location was updated in Beijing.
New
The overall status was updated to "Recruiting" at Xuan Wu Hospital Affiliated to Capital Medical University.
A location was updated in Beijing.
New
The overall status was updated to "Recruiting" at Tiantan Hospital Affiliated to Capital Medical University.
A location was updated in Beijing.
New
The overall status was updated to "Recruiting" at Second Artillery General Hospital of People's Liberation Army.
A location was updated in Beijing.
New
The overall status was updated to "Terminated" at Peking University First Hospital.
9 Jan '13
A location was updated in Beijing.
New
The overall status was updated to "Recruiting" at Tiantan Hospital Affiliated to Capital Medical University.
A location was updated in Beijing.
New
The overall status was updated to "Terminated" at Peking University First Hospital.