Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-03-03 @ 4:27 AM
Study NCT ID:
NCT03179618
Status:
UNKNOWN
Last Update Posted:
2017-06-07
First Post:
2017-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on the Clinical Effect of Xuefu Zhuyu Decoction in Treating Unstable Angina.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000789', 'term': 'Angina, Unstable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'C513826', 'term': 'Xue-Fu-Zhu-Yu decoction'}], 'ancestors': [{'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-05', 'studyFirstSubmitDate': '2017-06-05', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Six months after drug intervention', 'description': 'Death caused by cardiovascular disease'}], 'secondaryOutcomes': [{'measure': 'Myocardial enzymes', 'timeFrame': 'At baseline and 4 weeks after drug intervention', 'description': 'The unit is mmol/L'}, {'measure': '3. Blood lipid The unit is mmol/L. Blood lipid', 'timeFrame': 'At baseline and 4 weeks after drug intervention', 'description': '3\\. Blood lipid The unit is mmol/L. 3. Blood lipid The unit is mmol/L. The unit is mmol/L'}, {'measure': 'Treadmill exercise test', 'timeFrame': 'At baseline and 4 weeks after drug intervention', 'description': 'The result will be positive or negative'}, {'measure': 'The incidence of myocardial infarction or heart failure', 'timeFrame': 'Six months after drug intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Unstable Angina', 'Xuefu Zhuyu Decoction'], 'conditions': ['Unstable Angina']}, 'referencesModule': {'references': [{'pmid': '25254054', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '22536282', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '27777598', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23737852', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23762142', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants diagnosed with coronary heart disease through coronary angiography or coronary CTA;\n\nPatients have at least one of these symptoms:\n\n1. The stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration;\n2. Angina pectoris during rest;\n3. The recent occurrence of angina pectoris caused by mild physical activity in the last month.\n\nExclusion Criteria:\n\n* 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."}, 'identificationModule': {'nctId': 'NCT03179618', 'briefTitle': 'Research on the Clinical Effect of Xuefu Zhuyu Decoction in Treating Unstable Angina.', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'Research on the Clinical Effect of Xuefu Zhuyu Decoction in Treating Unstable Angina.', 'orgStudyIdInfo': {'id': 'XFZY-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Qi stagnation and blood stasis', 'description': 'Patients in this group will be treated by Xuefu Zhuyu Decoction at the base of conventional western medicine.', 'interventionNames': ['Drug: Anti-Platelet Drugs', 'Drug: Lipid Regulating Drugs', 'Drug: Coronary Vasodilator', 'Drug: Xuefu Zhuyu Decoction']}, {'type': 'OTHER', 'label': 'Conventional western medicine', 'description': 'Patients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc.', 'interventionNames': ['Drug: Anti-Platelet Drugs', 'Drug: Lipid Regulating Drugs', 'Drug: Coronary Vasodilator']}], 'interventions': [{'name': 'Anti-Platelet Drugs', 'type': 'DRUG', 'description': 'Including aspirin and clopidogrel, etc.', 'armGroupLabels': ['Conventional western medicine', 'Qi stagnation and blood stasis']}, {'name': 'Lipid Regulating Drugs', 'type': 'DRUG', 'description': 'Mainly including statins', 'armGroupLabels': ['Conventional western medicine', 'Qi stagnation and blood stasis']}, {'name': 'Coronary Vasodilator', 'type': 'DRUG', 'description': 'Mainly including nitrates', 'armGroupLabels': ['Conventional western medicine', 'Qi stagnation and blood stasis']}, {'name': 'Xuefu Zhuyu Decoction', 'type': 'DRUG', 'description': 'Mainly including Peach Kernel, Safflower, Angelica, Bupleurum etc.', 'armGroupLabels': ['Qi stagnation and blood stasis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Panpan Tian', 'role': 'CONTACT', 'email': '15652388175@163.com', 'phone': '+86 15652388175'}], 'overallOfficials': [{'name': 'Jun Li, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jun Li', 'class': 'OTHER'}, 'collaborators': [{'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Jun Li', 'investigatorAffiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}}