A Phase 4 interventional study of Danhong injection and Standard medical care in Acute Stroke, sponsored by China Academy of Chinese Medical Sciences. Completed at 62 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-08.
Sponsored by China Academy of Chinese Medical Sciences · Phase 4, Interventional, and Treatment
The purpose of this study is to determine whether Danhong injection is effective in the treatment of acute ischemic stroke.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 1,503 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →China Academy of Chinese Medical Sciences is the lead sponsor of 61 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Danhong injection · Procedure: 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.
Procedure: Standard medical care · Drug: placebo
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.
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
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
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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China Academy of Chinese Medical Sciences