- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03179618
Research on the Clinical Effect of Xuefu Zhuyu Decoction in Treating Unstable Angina.
June 5, 2017 updated by: Jun Li
This study evaluates the clinical efficacy of Xuefu Zhuyu Decoction in the treatment of unstable angina pectoris.
All of the patients will be divided into 2 arms randomly.
One of the arms will be treated by conventional western medicine, the other one will be treated by Xuefu Zhuyu Decoction at the base of conventional western medicine.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Xuefu Zhuyu Decoction has the function of activating qi and promoting blood circulation, which will be used to treat patients with qi stagnation and blood stasis syndrome.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants diagnosed with coronary heart disease through coronary angiography or coronary CTA;
Patients have at least one of these symptoms:
- The stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration;
- Angina pectoris during rest;
- The recent occurrence of angina pectoris caused by mild physical activity in the last month.
Exclusion Criteria:
- Patients diagnosed with stable angina; Patients with acute myocardial infarction; Chest pain caused by congenital heart disease, valvular heart disease, severe neurosis or arrhythmia; The heart function grade is III or IV; Patients with acute cerebral infarction; Patients complicated with other serious primary diseases; Patients with acute infection in recent 2 weeks; Uncontrolled hypertension (the resting blood pressure >160/95mmHg within one week); Diabetics emerged with serious diabetic complications; Patients can't finish the questionnaire due to abnormal mental and nervous or mental disorders; Pregnant or lactating women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Conventional western medicine
Patients in this group will be treated by conventional western medicine, including anti-platelet drugss,lipid regulating drugs, coronary vasodilator, etc.
|
Mainly including statins
Mainly including nitrates
Including aspirin and clopidogrel, etc.
|
EXPERIMENTAL: Qi stagnation and blood stasis
Patients in this group will be treated by Xuefu Zhuyu Decoction at the base of conventional western medicine.
|
Mainly including statins
Mainly including nitrates
Including aspirin and clopidogrel, etc.
Mainly including Peach Kernel, Safflower, Angelica, Bupleurum etc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: Six months after drug intervention
|
Death caused by cardiovascular disease
|
Six months after drug intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myocardial enzymes
Time Frame: At baseline and 4 weeks after drug intervention
|
The unit is mmol/L
|
At baseline and 4 weeks after drug intervention
|
Treadmill exercise test
Time Frame: At baseline and 4 weeks after drug intervention
|
The result will be positive or negative
|
At baseline and 4 weeks after drug intervention
|
The incidence of myocardial infarction or heart failure
Time Frame: Six months after drug intervention
|
Six months after drug intervention
|
|
3. Blood lipid The unit is mmol/L. Blood lipid
Time Frame: At baseline and 4 weeks after drug intervention
|
3. Blood lipid The unit is mmol/L.
3. Blood lipid The unit is mmol/L.
The unit is mmol/L
|
At baseline and 4 weeks after drug intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wang J, Yu G. A Systems Biology Approach to Characterize Biomarkers for Blood Stasis Syndrome of Unstable Angina Patients by Integrating MicroRNA and Messenger RNA Expression Profiling. Evid Based Complement Alternat Med. 2013;2013:510208. doi: 10.1155/2013/510208. Epub 2013 May 14.
- Qiu Y, Xu H, Shi D. Traditional chinese herbal products for coronary heart disease: an overview of cochrane reviews. Evid Based Complement Alternat Med. 2012;2012:417387. doi: 10.1155/2012/417387. Epub 2012 Mar 28.
- Liu W, Xiong X, Yang X, Chu F, Liu H. The Effect of Chinese Herbal Medicine Gualouxiebaibanxia Decoction for the Treatment of Angina Pectoris: A Systematic Review. Evid Based Complement Alternat Med. 2016;2016:8565907. doi: 10.1155/2016/8565907. Epub 2016 Sep 29.
- Wang J, Yang X, Chu F, Chen J, He Q, Yao K, Teng F, Gao Y, Xing Y, Wu A, Xing Y. The effects of xuefu zhuyu and shengmai on the evolution of syndromes and inflammatory markers in patients with unstable angina pectoris after percutaneous coronary intervention: a randomised controlled clinical trial. Evid Based Complement Alternat Med. 2013;2013:896467. doi: 10.1155/2013/896467. Epub 2013 May 8.
- Yi GZ, Qiu YQ, Xiao Y, Yuan LX. The usefulness of xuefu zhuyu tang for patients with angina pectoris: a meta-analysis and systematic review. Evid Based Complement Alternat Med. 2014;2014:521602. doi: 10.1155/2014/521602. Epub 2014 Aug 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 1, 2017
Primary Completion (ANTICIPATED)
October 1, 2019
Study Completion (ANTICIPATED)
December 1, 2019
Study Registration Dates
First Submitted
June 5, 2017
First Submitted That Met QC Criteria
June 5, 2017
First Posted (ACTUAL)
June 7, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 7, 2017
Last Update Submitted That Met QC Criteria
June 5, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XFZY-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unstable Angina
-
Korea University Anam HospitalCompletedDiabetic Stable Angina | Diabetic Unstable AnginaKorea, Republic of
-
Gennaro SardellaUnknownNon ST Segment Elevation MI and Unstable AnginaItaly
-
Bon-Kwon KooSamsung Medical Center; Chonnam National University Hospital; Seoul National... and other collaboratorsCompleted
-
Ulsan University HospitalSeoul National University HospitalCompletedStable Angina | Unstable AnginaKorea, Republic of
-
University Hospital TuebingenAcrostakUnknownMyocardial Ischemia | Stable or Unstable Angina PectorisGermany
-
CID - Carbostent & Implantable DevicesCompletedStable Angina | Unstable Angina | NSTEMINetherlands, Italy
-
Medhub Ltd.CompletedStable Angina | Unstable Angina | NSTEMIIsrael
-
Ospedale San DonatoTerminatedStable Angina | Unstable AnginaItaly
-
Jun LiUnknown
-
Jun LiGuang'anmen Hospital of China Academy of Chinese Medical SciencesUnknown
Clinical Trials on Lipid Regulating Drugs
-
Kumamoto UniversityCompletedMyocardial InfarctionJapan
-
Institute for Clinical Evaluative SciencesHeart and Stroke Foundation of Ontario; The Ontario Spor Support Unit; CorHealth... and other collaboratorsRecruitingCardiovascular Diseases | Dyslipidemias | Cardiovascular Risk FactorCanada
-
Aarhus University HospitalHeartFlow, Inc.Completed
-
AmgenRecruitingMajor Cardiovascular Event | Established Atherosclerotic Cardiovascular DiseaseChina
-
Hanlim Pharm. Co., Ltd.RecruitingMixed DyslipidemiaKorea, Republic of
-
Centro Cardiopatici ToscaniAzienda USL 4 PratoRecruitingAcute Coronary SyndromeItaly
-
Children's Hospital of Fudan UniversityCompletedKawasaki Disease | Coronary Artery AbnormalitiesChina
-
Ohio State UniversityNational Institute on Minority Health and Health Disparities (NIMHD); National...CompletedDyslipidemia | Hypercholesterolemia | HyperlipidemiaUnited States
-
Zibo Central HospitalUnknownAtherosclerosisChina
-
Duke UniversitySanofi; Regeneron PharmaceuticalsCompletedSmoking | Stroke | Hypertension | Cardiovascular Disease | Diabetes | Peripheral Arterial Disease | Atherosclerosis | Carotid Stenosis | Hypercholesterolemia | Hyperlipidemia | Claudication | Unstable Angina | Coronary Artery Disease (CAD) | Chronic Kidney Disease (CKD) | Angina | Transient Ischemic Attack (TIA) | Myocardial...United States