Danhong Injection in the Treatment of Acute Ischemic Stroke
A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Acute Ischemic Stroke
1 other identifier
interventional
1,503
1 country
62
Brief Summary
The purpose of this study is to determine whether Danhong injection is effective in the treatment of acute ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2013
Longer than P75 for phase_4
62 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
August 29, 2012
CompletedFirst Posted
Study publicly available on registry
August 31, 2012
CompletedStudy Start
First participant enrolled
March 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2019
CompletedJune 8, 2022
June 1, 2022
6 years
August 29, 2012
June 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Rankin Scale 0-1 (favourable outcome) at Day 90
Day 90
Secondary Outcomes (10)
The Score of effect on symptoms of "Xueyue Zheng"(Blood Stasis syndrome)
Day 0, Day7, Day 14, Day 30, Day 60, Day 90
Barthel Index score ≥90
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
EQ-5D scale
Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Global disability on mRS at Day 90.
Day 90
- +5 more secondary outcomes
Other Outcomes (2)
The changes on the profiles of micro-RNA in 96 patients selected from certain centers
Day 0, Day 14, Day 90
The changes on the expression profiles of mRNA in 96 patients selected from certain centers
Day 0, Day 14, Day 90
Study Arms (2)
Danhong injection
EXPERIMENTALBased 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
PLACEBO COMPARATORBased 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.
Interventions
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
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- ≤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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
The Second Artillery General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 100088, China
Xinqiao Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, 400037, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404000, China
Guangdong No.2 Provincial People's Hospital
Guangzhou, Guangdong, 510317, China
Guangzhou hospital of integrated Chinese and Western medicine
Guangzhou, Guangdong, 510813, China
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, 518028, China
The Second Central Hospital of Baoding City
Baoding, Hebei, 072750, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067000, China
Handan Central Hospital
Handan, Hebei, 056001, China
The Second Affiliated Hopital of Harbin Medical University
Harbin, Helongjiang, 150001, China
The Second Chinese Medical Hospital of Luoyang City
Luoyang, Henan, 471003, China
Nanyang T.C.M. Hospital
Nanyang, Henan, 473007, China
Nanshi Hospital of Nanyang
Nanyang, Henan, 473065, China
The First Affiliated Hospital of Henan University of T.C.M.
Zhengzhou, Henan, 450000, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450003, China
Zhengzhou NO.7 People's Hospital
Zhengzhou, Henan, 450006, China
Zhoukou Hospital of T.C.M.
Zhoukou, Henan, 466099, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430014, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430030, China
Zhongshan Hospital of Hubei Province
Wuhan, Hubei, 430033, China
Fifth Hospital in Wuhan
Wuhan, Hubei, 430050, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Tianyou Hospital Affiliated to Wuhan University of Science & Technology
Wuhan, Hubei, 430064, China
Huangpi District Hospital of T.C.M.
Wuhan, Hubei, 430399, China
Changsha Central Hospital
Changsha, Hunan, 410004, China
The First Hospital of Changsha
Changsha, Hunan, 410005, China
The second people's hospital of Hunan Province
Changsha, Hunan, 410007, China
Xiangya Hospital Central-south University
Changsha, Hunan, 410008, China
Nanjing Hospital of T.C.M.
Nanjing, Jiangsu, 210001, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210003, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Jilin Province People's Hospital
Changchun, Jilin, 130021, China
The Affiliated Hopital to Changchun University of Chinese Medicine
Changchun, Jilin, 130021, China
The First Hospital Affiliated to Jilin University
Changchun, Jilin, 130021, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
Liaoyuan Traditional Chinese Medical Hospital
Liaoyuan, Jilin, 136299, China
Anshan Central Hospital
Anshan, Liaoning, 114001, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001, China
Dandong First Hospital
Dandong, Liaoning, 118015, China
Panjin Central Hospital
Panjin, Liaoning, 124013, China
People's Liberation Army No.202 Hospital
Shenyang, Liaoning, 110003, China
The General Hospital of Shenyang Military
Shenyang, Liaoning, 110016, China
People's Liberation Army No.463 Hospital
Shenyang, Liaoning, 110046, China
Affiliated Hospital of Chifeng University
Chifeng, Neimenggu, 024005, China
Fenyang Hospital of Shanxi Province
Lüliang, Shanxi, 032299, China
The Second Affiliated Hospital to Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Affiliated Hospital of Shanxi University of Chinese Medicine
Xianyang, Shanxi, 712000, China
The Second Affiliated Hospital of Shanxi University of T.C.M.
Xianyang, Shanxi, 712000, China
Shanxi Province Hospital of T.C.M.
Xi’an, Shanxi, 710003, China
The PLA Fourth Fifty-one Hospital
Xi’an, Shanxi, 710054, China
Shanxi Provincial People's Hospital
Xi’an, Shanxi, 710068, China
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610072, China
The First Affiliated Hopital of Chengdu Medical College
Chengdu, Sichuan, 610500, China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193, China
Xin Hua Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310005, China
Zhejiang Provincial Hospital of T.C.M.
Hangzhou, Zhejiang, 310006, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Huzhou Central Hospital
Huzhou, Zhejiang, 313003, China
Peking University First Hospital
Beijing, 100034, China
Tiantan Hospital Affiliated to Capital Medical University
Beijing, 100050, China
Xuan Wu Hospital Affiliated to Capital Medical University
Beijing, 100053, China
Related Publications (1)
Li B, Wang Y, Lu J, Liu J, Yuan Y, Yu Y, Wang P, Zhao X, Wang Z. Evaluating the effects of Danhong injection in treatment of acute ischemic stroke: study protocol for a multicenter randomized controlled trial. Trials. 2015 Dec 9;16:561. doi: 10.1186/s13063-015-1076-4.
PMID: 26654631DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 29, 2012
First Posted
August 31, 2012
Study Start
March 13, 2013
Primary Completion
March 10, 2019
Study Completion
March 27, 2019
Last Updated
June 8, 2022
Record last verified: 2022-06