The purpose of this study is to determine the efficacy and safety of Danhong injection in the treatment of unstable angina pectoris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
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 unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) (2007) issued by Chinese Society of Cardiology of Chinese Medical Association
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.
Xuanwu Hospital
Beijing, Beijing Municipality, China
Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Change from baseline of the Quantification score of angina pectoris at Day 7
Quantification score of angina pectoris is a 4-item questionnaire that quantifies the frequency of angina, the duration of angina at every attack, the severity of angina and the use of nitroglycerin in a week. Scores range from 0 to 24; higher scores indicate worse health status.
Time frame: Day 7
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
Use of Short-acting Nitrates
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28
Change in the electrocardiogram (ECG)
ECG will be done five times every day, when 5-10 min before use of nitrates or Danhong injection, 5-10 min after use of nitrates or Danhong injection, at the time 22:00. If there is an angina attack, an additional ECG should be done when the angina attacks.
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28
The proportion of patients who are undergoing PCI
Time frame: Day 7, Day 28
Change in Seattle Angina Questionnaire
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.
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The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
Harbin, Heilongjiang, China
Zhengzhou No.7 People's Hospital
Zhengzhou, Henan, China
The First Hospital of Changsha
Changsha, Hunan, China
The Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, China
Hospital 463 of P.L.A.
Shenyang, Liaoning, China
First Teaching Hospital of Tianjin University of T.C.M.
Tianjin, Tianjin Municipality, China
Time frame: Day 0, Day 28
Incidence of adverse events (including serious adverse events) in 28 days
Time frame: 28 days