A Phase 4 interventional study of Danhong injection and Standard medical care in Unstable Angina Pectoris, sponsored by China Academy of Chinese Medical Sciences. Completed at 9 sites in China. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-12-02.
Sponsored by China Academy of Chinese Medical Sciences · Phase 4, Interventional, and Treatment
The purpose of this study is to determine the efficacy and safety of Danhong injection in the treatment of unstable angina pectoris.
282 studies on the registry are indexed under Angina, Unstable; 36 are open to participants now.
This study's enrollment of 160 is below the median of 180 across 177 interventional studies indexed under Angina, Unstable.
Browse Angina, Unstable studies →China Academy of Chinese Medical Sciences is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
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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 2-3 hours every day for 7 days.
Drug: Danhong injection · Other: Standard medical care
Based on the standard medical care, placebo was 40ml of 0.9% saline, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2-3 hours every day for 7 days.
Other: Standard medical care · Drug: Placebo
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.
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.
Time frame: Day 0, Day 28
Incidence of adverse events (including serious adverse events) in 28 days
Time frame: 28 days
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Danhong formula
China Academy of Chinese Medical Sciences