Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT03478332
Status:
UNKNOWN
Last Update Posted:
2018-03-27
First Post:
2018-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628007', 'term': 'Yangxinshi'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-08-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2018-02-11', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': '24 months', 'description': 'Number of treatment-related adverse events as assessed by CTCAE4.0'}], 'primaryOutcomes': [{'measure': 'change in the maximum volume of O2 consumption', 'timeFrame': 'from baseline to 6 months', 'description': 'measured by gas analyzer'}], 'secondaryOutcomes': [{'measure': 'change in exercise tolerance', 'timeFrame': 'from baseline to 6 months', 'description': 'assessed by the distance (in meters) walked on 6-minute walk test'}, {'measure': 'change in left ventricular ejection fraction (in percentage)', 'timeFrame': 'from baseline to 6 months', 'description': 'assessed by echocardiographic examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'Compared with conventional treatment of the coronary heart disease,the aim of the research is to find out if the addition of Yangxinshi pills on the basis of conventional treatment can improve exercise tolerance of patients with coronary heart disease, improve quality of life or restore social function and mental health', 'detailedDescription': '90 outpatients with clear diagnosis of coronary heart diseases will be recruited in the trial and randomized into two group.\n\nOne group are treated with Yangxinshi pills (provided by Qingdao Growtful Pharmaceutical Co., Ltd.) plus conventional medicine, the other group are treated with placebo plus conventional medicine.\n\nThe primary end point is VO2max measured by cardiopulmonary exercise test after 3 months of treatment.\n\nThe secondary endpoint is:\n\n1. Mets, Anaerobic threshold（AT）measured by cardiopulmonary exercise test；\n2. Changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test；\n3. The maximum walking distance of 6-minute walk test;\n4. Changes of Seattle Angina Questionnaire;\n5. Hamilton Depression Scale/ Hamilton Anxiety Scale.\n\nThe safety evaluation criteria is:\n\n1. Adverse event and serious adverse event;\n2. Vital signs;\n3. Resting 12 lead ECG;\n4. Blood routine examination , urine routine examination、liver and renal function examination(AST、ALT、BUN、Cr).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40 \\~ 75, gender is not limited\n* Have a clear history or ECG of hospital myocardial infarction , diagnosed as coronary heart disease by imaging diagnosis\n* Sign the informed consent voluntarily\n\nExclusion Criteria:\n\n* History of hospitalization for acute coronary syndrome in past 3 months\n* Uncontrolled grade 3 hypertension（≥180/100mmHg）or hypotension（\\<90/60mmHg）\n* History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months\n* In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth\n* Combined episode bronchial asthma or chronic obstructive pulmonary disease, bradycardia (resting heart rate \\<60bpm) or atrioventricular block\n* Severely allergic constitution, known or likely to be allergic to the test drug or its components\n* Known bleeding tendency or hemorrhagic disease\n* Patients with severe liver and kidney dysfunction (creatinine clearance ≤ 40ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 2 × upper limit of clinical reference), other life-threatening serious primary or psychiatric diseases and malignant tumors\n* Any other situations that researchers believe may affect the clinical research'}, 'identificationModule': {'nctId': 'NCT03478332', 'briefTitle': 'Effects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Changchun University of Chinese Medicine'}, 'officialTitle': 'Yangxinshi Pills Plus Conventional Treatment Versus Placebo Plus Conventional Treatment on the Exercise Tolerance of the Patients With Coronary Heart Disease: a Multi-center,Randomised Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'GFH-C04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group', 'description': 'The aim of the arm is to test if the addition of Yangxinshi pills to the conventional coronary heart disease medicine will improve the exercise tolerance of the coronary heart disease', 'interventionNames': ['Drug: Yangxinshi pill', 'Drug: conventional coronary heart disease medicine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant', 'interventionNames': ['Drug: conventional coronary heart disease medicine', 'Drug: Placebos']}], 'interventions': [{'name': 'Yangxinshi pill', 'type': 'DRUG', 'otherNames': ['STATE MEDICAL PERMISSION No.Z37021103'], 'description': '0.6g/tablet', 'armGroupLabels': ['Treatment group']}, {'name': 'conventional coronary heart disease medicine', 'type': 'DRUG', 'otherNames': ['glyceryl trinitrate， beta-Blocking agent，etc'], 'description': 'the conventional treatment includes medicines treating coronary heart disease', 'armGroupLabels': ['Control group', 'Treatment group']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['Yangxinshi simulant'], 'description': 'Yangxinshi simulant', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoping Meng, Doctor', 'role': 'CONTACT', 'email': '18994127461@163.com', 'phone': '8618994127461'}], 'facility': 'Changchun Traditional Medicine University Affiliated Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Xiaoping Meng, Doctor', 'role': 'CONTACT', 'email': '18994127461@163.com', 'phone': '8618994127461'}], 'overallOfficials': [{'name': 'Xiaoping Meng, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changchun Traditional Medicine University Affiliated Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital of Changchun University of Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Xiaoping Meng', 'investigatorAffiliation': 'Affiliated Hospital of Changchun University of Chinese Medicine'}}}}