Danhong Injection in the Treatment of Chronic Stable Angina | NCT01681316

Status Module

Name	Class
China Food and Drug Administration	OTHER_GOV

Arms/Interventions Module

Arm Groups

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 hours.	Drug: Danhong injection Other: Standard medical care
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 hours.	Other: Standard medical care Drug: Placebo

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	Danhong injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Day 30

Secondary Outcomes

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, Day 14, Day 30, Day 60, Day 90

Other Outcomes

Measure	Description	Time Frame
The profiles of micro-RNA in 60 patients selected from certain centers		Day 0, Day 14, Day 90
The profiles of mRNA in 60 patients selected from certain centers		Day 0, Day 14, Day 90

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female or male inpatients.
Age: 18 - 70 years.
Patients with clinical diagnosis of chronic stable angina and must meet one of the following conditions:1）Patients who have a history of myocardial infarction and ST-T changes;2）Stenosis of more than 50% in at least one major epicardial coronary artery shown by Coronary Angiograph or CT Angiography; 3）Patients with coronary heart disease were determined by radionuclide angiocardiography.
Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in angina ≥ 15. The Chinese medicine symptoms scales of "Xueyu Zheng" is defined as following (1)chest pain-10, (2)chest distress-10, (3) palpitation-5, (4)purple or dark lip-5, (5) purple or dark tongue-5, (6) unsmooth pulse-5.
Patients with moderate angina pectoris (The definition of "moderate angina pectoris " is in accordance with the Canadian Cardiovascular Society (CCS) grading of angina pectoris,which be classified to II or III.
Patient is willing to participate voluntarily and to sign a written patient informed consent.

Exclusion Criteria:

Woman with pregnancy, lactation or positive result of pregnancy test, or woman who is under menstrual period.
Woman who disagree with contraception during treatment period
Patients with severe complications that would make the condition more complicated assessed by the investigator, including liver or renal dysfunction, severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, a history of epilepsy or cerebral hemorrhage .
Patients who were angina-free during the run-in period without taking any drug.
Patients with myocardial infarction or Canadian Cardiovascular Society (CCS) grading of angina pectoris class IV within the preceding 3 months
Patients with chest pain caused by other disease (e.g., acute myocardial infarction，severe neurosis，menopausal syndrome，hyperthyroidism).
Patients with history of drug-induced bleeding or history of bleeding caused by warfarin.
Patients with history of hematopoietic system diseases.
Patients who had surgery within the past 4 weeks and have hemorrhagic tendency.
Patients who is participating in other trials or has been participated in other trials in recent 3 months.
Patients with history of allergy or suspected allergic to the drug.
Patients who were suspected addicted into alcohol or drug abuse in the past 2 years.
Patients with mental disorder.
Patients who were unable to participate in the study as judged by investigator.
Patients who were family members or relatives of the research center staffs.

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Zhong Wang, Professor	Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences	Principal Investigator
Yun-dai Chen, Professor	Chinese PLA General Hospital(301 Hospital)	Principal Investigator
Yong-yan Wang, Professor	Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences	Study Chair
Xiao-xi Du, Professor	China Food and Drug Administration	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Guang'anmen Hospital, China Academy of Chinese Medical Sciences		Beijing	Beijing Municipality	100053	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36945217	Derived	Guan S, Yu YN, Li B, Gu H, Chen L, Wang N, Wang B, Liu X, Liu J, Wang Z. Discovery of Drug-Responsive Phenomic Alteration-Related Driver Genes in the Treatment of Coronary Heart Disease. Pharmgenomics Pers Med. 2023 Mar 15;16:201-217. doi: 10.2147/PGPM.S398522. eCollection 2023.
34471087	Derived	Liu J, Li DD, Dong W, Liu YQ, Wu Y, Tang DX, Zhang FC, Qiu M, Hua Q, He JY, Li J, Du B, Du TH, Niu LL, Jiang XJ, Cui B, Chen JB, Wang YG, Wang HR, Yu Q, He J, Mao YL, Bin XF, Deng Y, Tian YD, Han QH, Liu DJ, Duan LQ, Zhao MJ, Zhang CY, Dai HY, Li ZH, Xiao Y, Hu YZ, Huang XY, Xing K, Jiang X, Liu CF, An J, Li FC, Tao T, Jiang JF, Yang Y, Dong YR, Zhang L, Fu G, Li Y, Huang SW, Dou LP, Sun LJ, Zhao YQ, Li J, Xia Y, Liu J, Liu F, He WJ, Li Y, Tan JC, Lin Y, Zhou YB, Yang JF, Ma GQ, Chen HJ, Liu HP, Liu ZW, Liu JX, Luo XJ, Bin XH, Yu YN, Dang HX, Li B, Teng F, Qiao WM, Zhu XL, Chen BW, Chen QG, Shen CT, Wang YY, Chen YD, Wang Z. Detection of an anti-angina therapeutic module in the effective population treated by a multi-target drug Danhong injection: a randomized trial. Signal Transduct Target Ther. 2021 Sep 1;6(1):329. doi: 10.1038/s41392-021-00741-x.

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D002637	Chest Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms