The purpose of this study is to determine whether Danhong injection is effective in the treatment of acute ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,503
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.
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)
The improvement of the NIHSS score ≥4 or the NIHSS score of 0 to 1
Time frame: Day 0, Day7, Day 14, Day 30, Day 60, Day 90
EQ-5D scale
Time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Global disability on mRS at Day 90.
The proportion of patients with mRS ≥3 at Day 90.
Time frame: Day 90
Incidence of new-onset major vascular events in 90 days
Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
Time frame: Day 90
Overall mortality at day 90
Time frame: Day 90
Incidence of severe hemorrhages in 90 days
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.
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The Second Artillery General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Xinqiao Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Guangdong No.2 Provincial People's Hospital
Guangzhou, Guangdong, China
Guangzhou hospital of integrated Chinese and Western medicine
Guangzhou, Guangdong, China
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
The Second Central Hospital of Baoding City
Baoding, Hebei, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
Handan Central Hospital
Handan, Hebei, China
The Second Affiliated Hopital of Harbin Medical University
Harbin, Helongjiang, China
...and 52 more locations
Time frame: Day 90
Incidence of moderate hemorrhages in 90 days
The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.
Time frame: Day 90
Documentation of adverse events (AEs) and serious AEs
Time frame: 90 days