The purpose of this study is to evaluate the effect of Danhong Injection on the relief of angina with the use of the Seattle Angina Questionnaire among patients with stable angina patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
920
A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).
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.
The proportion of patients in each treatment group who had clinically significant change as defined by the angina-frequency score on the Seattle Angina Questionnaire at day 30
Seattle Angina Questionnaire, a 19-item questionnaire that quantifies physical limitations due to angina, any recent change in the severity of angina, the frequency of angina, satisfaction with treatment, and quality of life. Scores range from 0 to 100; higher scores indicate better health status.With a score of 20 or more on the angina-frequency scale indicating that the patient was clinically significant change.
Time frame: Day 30
Total score of symptoms questionnaire of TCM
The symptoms questionnaire of TCM consists of 6 symptoms that described in traditional Chinese medicine, including chest pain, chest distress, palpitation, dark-purple lip, dark-purple tongue and unsmooth pulse. Each symptom was assessed by the Visual Analogue Scale(VAS),where a higher score meant higher severity.
Time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
The proportion of patients in each treatment group who had clinically significant changes in the other four Seattle Angina Questionnaire scales (The physical limitation, angina stability, treatment satisfaction, and quality of life)
We defined clinical significant changes as a difference of 8 points or more on the physical-limitation scale, 25 or more on the angina-stability scale, 12 or more on the treatment-satisfaction scale, or 16 or more on the quality-of-life scale.
Time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
The frequency of anginal attack every week
The frequency of anginal attack was recorded by the patients with the use of the diary cards which will be collected from the run-in period (Day -7) to the end of follow-up (Day 90).
Time frame: Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
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Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Xuan Wu Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Dongfang Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital(301 Hospital)
Beijing, Beijing Municipality, China
Chongqing Traditional Chinese Medicine Hopital
Chongqing, Chongqing Municipality, China
The Third People's Hospital of Chongqing
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
Harbin, Heilongjiang, China
The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of T.C.M.
Zhengzhou, Henan, China
...and 21 more locations
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Consumption of Short-acting Nitrates
Time frame: Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Change in the electrocardiogram (EKG)
Time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate
Time frame: Day 0, Day 14
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 in 90 days
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