Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| China Food and Drug Administration | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the efficacy and safety of Danhong injection in the treatment of unstable angina pectoris.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danhong injection | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danhong injection | Drug | A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0, Day 7 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhong Wang, M.D., Ph.D. | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Principal Investigator |
| Xian Wang, M.D. | Dongzhimen Hospital, Beijing | Principal Investigator |
| Xiao-xi Du, Professor | China Food and Drug Administration | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Beijing | Beijing Municipality | 100053 | China | ||
| Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34732357 | Derived | Chen L, Fu G, Hua Q, Zhu HY, Deng Y, Wu W, Zhao YJ, Yang XY, Yang BS, Zhou YB, Liu J, Yu YN, Chen BW, Wang X, Wang Z. Efficacy of add-on Danhong injection in patients with unstable angina pectoris: A double-blind, randomized, placebo-controlled, multicenter clinical trial. J Ethnopharmacol. 2022 Feb 10;284:114794. doi: 10.1016/j.jep.2021.114794. Epub 2021 Oct 31. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540581 | danhong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard medical care | Other | 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 |
|
| Placebo | Drug | 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. |
|
| Use of Short-acting Nitrates | 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. | 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 | 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. | Day 0, Day 28 |
| Incidence of adverse events (including serious adverse events) in 28 days | 28 days |
| Beijing |
| Beijing Municipality |
| 100700 |
| China |
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | Guangdong | 510405 | China |
| The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine | Harbin | Heilongjiang | 150040 | China |
| Zhengzhou No.7 People's Hospital | Zhengzhou | Henan | 450006 | China |
| The First Hospital of Changsha | Changsha | Hunan | 410005 | China |
| The Affiliated Hospital to Changchun University of Chinese Medicine | Changchun | Jilin | 130021 | China |
| Hospital 463 of P.L.A. | Shenyang | Liaoning | 110046 | China |
| First Teaching Hospital of Tianjin University of T.C.M. | Tianjin | Tianjin Municipality | 300193 | China |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |