Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-05 @ 3:39 PM
Study NCT ID:
NCT06699420
Status:
RECRUITING
Last Update Posted:
2024-11-21
First Post:
2024-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Qishenyiqi Dripping Pill for Coronary Microvascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017566', 'term': 'Microvascular Angina'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up', 'timeFrame': '1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Microvascular Disease']}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy and safety of Qishenyiqi in patients with microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Qishenyiqi on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;\n* Coronary normal or stenosis \\< 20%;\n* Ischemic depression in ST segment during resting or exercise;\n* Blood flow reserve (CFR) of the anterior descending coronary artery \\< 2.0;\n* Subjects or their guardians agreed to participate in this study.\n\nExclusion Criteria:\n\n* Previous myocardial infarction or PCI or CABG treatment;\n* A history of heart failure;\n* Severe arrhythmia;\n* Refractory hypertension or hypertension accompanied by left ventricular wall thickness \\> 12 mm;\n* Familial hypercholesterolemia;\n* Takayasu arteritis, Kawasaki disease or coronary artery malformation;\n* Pregnant or nursing, or having the intention to give birth within one year;\n* Hepatic or renal dysfunction;\n* Allergic to contrast agents or traditional Chinese medicines;\n* Patients who participated in clinical research of other drugs within 3 months before being selected.'}, 'identificationModule': {'nctId': 'NCT06699420', 'acronym': 'CMVD', 'briefTitle': 'Qishenyiqi Dripping Pill for Coronary Microvascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'The Efficacy and Safety of Qishenyiqi Dripping Pill in Patients With Coronary Microvascular Disease', 'orgStudyIdInfo': {'id': 'Qishenyiqi for CMVD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Qishenyiqi Dripping Pill', 'interventionNames': ['Drug: Qishenyiqi dripping pills 1 bag, three times a day']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo 1 bag, three times a day']}], 'interventions': [{'name': 'Qishenyiqi dripping pills 1 bag, three times a day', 'type': 'DRUG', 'description': 'Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months', 'armGroupLabels': ['Qishenyiqi Dripping Pill']}, {'name': 'Placebo 1 bag, three times a day', 'type': 'DRUG', 'description': 'Placebo, 1 bag once, three times a day, 12 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Qianfoshan Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Panpan Hao, Dr', 'role': 'CONTACT', 'email': 'panda.how@sdu.edu.cn', 'phone': '18560086593'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '250031', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Li, Dr', 'role': 'CONTACT', 'email': 'qingquan0615@163.com', 'phone': '13370586671'}], 'facility': 'Jinan Central Hospital Affiliated to Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Panpan Hao, Dr.', 'role': 'CONTACT', 'email': 'panda.how@sdu.edu.cn', 'phone': '8618560086593'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Pan-Pan Hao', 'investigatorAffiliation': 'Qilu Hospital of Shandong University'}}}}