Danhong Injection in the Treatment of Chronic Stable Angina
A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina
1 other identifier
interventional
920
1 country
31
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2012
Longer than P75 for phase_4
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2012
CompletedFirst Posted
Study publicly available on registry
September 7, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 12, 2016
October 1, 2016
3.8 years
September 5, 2012
October 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (12)
Total score of symptoms questionnaire of TCM
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）
Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
The frequency of anginal attack every week
Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Consumption of Short-acting Nitrates
Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
- +7 more secondary outcomes
Other Outcomes (2)
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
Study Arms (2)
Danhong injection
EXPERIMENTALBased 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.
Placebo
PLACEBO COMPARATORBased 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053, China
Xuan Wu Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100053, China
Dongfang Hospital
Beijing, Beijing Municipality, 100078, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Chinese PLA General Hospital(301 Hospital)
Beijing, Beijing Municipality, 100853, China
Chongqing Traditional Chinese Medicine Hopital
Chongqing, Chongqing Municipality, 400011, China
The Third People's Hospital of Chongqing
Chongqing, Chongqing Municipality, 400014, China
The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
Harbin, Heilongjiang, 150009, China
The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
Harbin, Heilongjiang, 150040, China
The First Affiliated Hospital of Henan University of T.C.M.
Zhengzhou, Henan, 450000, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450053, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Hubei Provincial Hospital of T.C.M.
Wuhan, Hubei, 430061, China
Changsha Central Hospital
Changsha, Hunan, 410004, China
The First Hospital of Changsha
Changsha, Hunan, 410005, China
The Second Affiliated Hospital to Hunan University of Chinese Medicine
Changsha, Hunan, 410005, China
Jilin Province People's Hospital
Changchun, Jilin, 130021, China
The Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, 130021, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001, China
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065, China
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200071, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
The First Affiliated Hospital to Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Affiliated Hospital of Shanxi University of Chinese Medicine
Xianyang, Shanxi, 712000, China
Xi'an City Hospital of T.C.M.
Xi’an, Shanxi, 710001, China
Shanxi Province Hosptial of T.C.M.
Xi’an, Shanxi, 710003, China
Shanxi Provincial People's Hospital
Xi’an, Shanxi, 710068, China
Chengdu Sencond People's Hospital
Chengdu, Sichuan, 610017, China
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300150, China
Xin Hua Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310005, China
Related Publications (3)
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.
PMID: 36945217DERIVEDLiu 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.
PMID: 34471087DERIVEDWang PQ, Li DD, Dong W, Liu J, Yu YN, Shen CT, Chen QG, Chen BW, Chen YD, Wang Z. Danhong injection in the treatment of chronic stable angina: study protocol for a randomized controlled trial. Trials. 2015 Oct 21;16:474. doi: 10.1186/s13063-015-0998-1.
PMID: 26489511DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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)
- STUDY CHAIR
Yong-yan Wang, Professor
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
- STUDY DIRECTOR
Xiao-xi Du, Professor
China Food and Drug Administration
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Study Record Dates
First Submitted
September 5, 2012
First Posted
September 7, 2012
Study Start
December 1, 2012
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
October 12, 2016
Record last verified: 2016-10