Danhong Injection in the Treatment of Acute Ischemic Stroke
- Conditions
- Acute Stroke
- Interventions
- Drug: Danhong injectionProcedure: Standard medical careDrug: placebo
- Registration Number
- NCT01677208
- Lead Sponsor
- China Academy of Chinese Medical Sciences
- Brief Summary
The purpose of this study is to determine whether Danhong injection is effective in the treatment of acute ischemic stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1503
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Danhong injection 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. Danhong injection Standard medical care 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. placebo Standard medical care 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. placebo 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.
- Primary Outcome Measures
Name Time Method Modified Rankin Scale 0-1 (favourable outcome) at Day 90 Day 90
- Secondary Outcome Measures
Name Time Method Documentation of adverse events (AEs) and serious AEs 90 days Barthel Index score ≥90 Day 0, Day7, Day 14, Day 30, Day 60, Day 90 Incidence of moderate hemorrhages in 90 days 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.
Incidence of new-onset major vascular events in 90 days Day 90 Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
Overall mortality at day 90 Day 90 The Score of effect on symptoms of "Xueyue Zheng"(Blood Stasis syndrome) Day 0, Day7, Day 14, Day 30, Day 60, Day 90 NIH stroke scale(NIHSS) 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 Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 Global disability on mRS at Day 90. Day 90 The proportion of patients with mRS ≥3 at Day 90.
Incidence of severe hemorrhages in 90 days 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.
Trial Locations
- Locations (62)
Xinqiao Hospital of Third Military Medical University
🇨🇳Chongqing, Chongqing, China
Chongqing Three Gorges Central Hospital
🇨🇳Chongqing, Chongqing, China
Guangzhou hospital of integrated Chinese and Western medicine
🇨🇳Guangzhou, Guangdong, China
Fifth Hospital in Wuhan
🇨🇳Wuhan, Hubei, China
Handan Central Hospital
🇨🇳Handan, Hebei, China
The Second Chinese Medical Hospital of Luoyang City
🇨🇳Luoyang, Henan, China
The second people's hospital of Hunan Province
🇨🇳Changsha, Hunan, China
Affiliated Hospital of Shanxi University of Chinese Medicine
🇨🇳Xianyang, Shanxi, China
The Second Affiliated Hospital of Shanxi University of T.C.M.
🇨🇳Xianyang, Shanxi, China
Huzhou Central Hospital
🇨🇳Huzhou, Zhejiang, China
Xin Hua Hospital of Zhejiang Province
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Xuan Wu Hospital Affiliated to Capital Medical University
🇨🇳Beijing, China
The Second Artillery General Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
Guangdong No.2 Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Zhengzhou NO.7 People's Hospital
🇨🇳Zhengzhou, Henan, China
Nanshi Hospital of Nanyang
🇨🇳Nanyang, Henan, China
The Second Affiliated Hopital of Harbin Medical University
🇨🇳Harbin, Helongjiang, China
The First Affiliated Hospital of Henan University of T.C.M.
🇨🇳Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
The First Hospital of Changsha
🇨🇳Changsha, Hunan, China
Tianyou Hospital Affiliated to Wuhan University of Science & Technology
🇨🇳Wuhan, Hubei, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Changsha Central Hospital
🇨🇳Changsha, Hunan, China
Fenyang Hospital of Shanxi Province
🇨🇳Luliang, Shanxi, China
The PLA Fourth Fifty-one Hospital
🇨🇳Xi'an, Shanxi, China
Dandong First Hospital
🇨🇳Dandong, Liaoning, China
Zhejiang Provincial Hospital of T.C.M.
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hopital of Chengdu Medical College
🇨🇳Chengdu, Sichuan, China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
🇨🇳Tianjin, Tianjin, China
Tiantan Hospital Affiliated to Capital Medical University
🇨🇳Beijing, China
Nanjing Hospital of T.C.M.
🇨🇳Nanjing, Jiangsu, China
The Second People's Hospital of Shenzhen
🇨🇳Shenzhen, Guangdong, China
Affiliated Hospital of Chengde Medical University
🇨🇳Chengde, Hebei, China
The Second Central Hospital of Baoding City
🇨🇳Baoding, Hebei, China
Nanyang T.C.M. Hospital
🇨🇳Nanyang, Henan, China
People's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Zhoukou Hospital of T.C.M.
🇨🇳Zhoukou, Henan, China
The Central Hospital of Wuhan
🇨🇳Wuhan, Hubei, China
Zhongshan Hospital of Hubei Province
🇨🇳Wuhan, Hubei, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Huangpi District Hospital of T.C.M.
🇨🇳Wuhan, Hubei, China
Xiangya Hospital Central-south University
🇨🇳Changsha, Hunan, China
The First Hospital Affiliated to Jilin University
🇨🇳Changchun, Jilin, China
The Affiliated Hopital to Changchun University of Chinese Medicine
🇨🇳Changchun, Jilin, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Liaoyuan Traditional Chinese Medical Hospital
🇨🇳Liaoyuan, Jilin, China
Anshan Central Hospital
🇨🇳Anshan, Liaoning, China
People's Liberation Army No.463 Hospital
🇨🇳Shenyang, Liaoning, China
Panjin Central Hospital
🇨🇳Panjin, Liaoning, China
People's Liberation Army No.202 Hospital
🇨🇳Shenyang, Liaoning, China
The General Hospital of Shenyang Military
🇨🇳Shenyang, Liaoning, China
Affiliated Hospital of Chifeng University
🇨🇳Chifeng, Neimenggu, China
Shanxi Province Hospital of T.C.M.
🇨🇳Xi'an, Shanxi, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, Liaoning, China
Shanxi Provincial People's Hospital
🇨🇳Xi'an, Shanxi, China
The Second Affiliated Hospital to Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
🇨🇳Chengdu, Sichuan, China
Peking University First Hospital
🇨🇳Beijing, China