Danhong Injection in the Treatment of Unstable Angina Pectoris
NCT ID: NCT02007187
Last Updated: 2017-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2013-12-31
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Danhong injection
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.
Danhong injection
A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower
Standard medical care
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
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.
Standard medical care
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
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.
Interventions
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Danhong injection
A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower
Standard medical care
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
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
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Inclusion Criteria
* Age: 35 - 75 years.
* Patients with clinical diagnosis of unstable stable angina according to 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, including one of the following conditions.
* Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in UA ≥ 15. The Chinese medicine symptoms scales of "Xueyu Zheng" is a 6-item questionnaire including the symtoms 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.
* Patient is willing to participate voluntarily and to sign a written patient informed consent.
Exclusion Criteria
* Patients with history of infection, fever, trauma, surgery(exclude PCI) and inflammation in the past month;
* Patients with active tuberculosis or rheumatological disorders;
* Patients with renal dysfunction (Male: CCr\>2.5mg/dl; Female: CCr\>2.0mg/dl);
* Patients with liver dysfunction (any value of serum aminotransferase more than triple normal value);
* Patients with history of hematopoietic system diseases;
* Patients with mental disorder;
* Patients with history of drug-induced bleeding or history of bleeding caused by warfarin;
* Patients with malignant tumor;
* Patients with history of organ transplant;
* Woman with pregnancy, lactation or positive result of pregnancy test;
* Patients who is participating in other trials or has been participated in other trials in recent 3 months;
* Patients who were unable to participate in the study as judged by investigator.
35 Years
75 Years
ALL
No
Sponsors
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China Food and Drug Administration
OTHER_GOV
China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Zhong Wang
Professor
Principal Investigators
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Zhong Wang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Xian Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dongzhimen Hospital, Beijing
Xiao-xi Du, Professor
Role: STUDY_DIRECTOR
China Food and Drug Administration
Locations
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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
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
Countries
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References
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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.
Other Identifiers
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2011ZX09304-07V1.2
Identifier Type: -
Identifier Source: org_study_id