Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-31 @ 11:37 AM
Study NCT ID:
NCT04505228
Status:
COMPLETED
Last Update Posted:
2020-08-10
First Post:
2020-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C079426', 'term': 'Honghua extract, Carthamus tinctorius'}, {'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D012680', 'term': 'Sensitivity and Specificity'}, {'id': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-05', 'studyFirstSubmitDate': '2020-08-02', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'typical symptoms in patients with hypertensive bradyarrhythmia', 'timeFrame': '2 weeks', 'description': 'The five indexes of typical symptoms in patients with hypertensive bradyarrhythmia (palpitation, angina, shortness of breath, dizzy, lumbar debility) were evaluated and scored both before treatment and after treatment according to "Guiding principles for clinical research of new Chinese Medicine".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertensive Heart Disease']}, 'descriptionModule': {'briefSummary': '72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded and used for evaluation of treatment.', 'detailedDescription': 'To test the effect of Chinese herb against the hypertensive heart disease, we designed this randomized controlled clinical trial. 72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. 2 weeks after treatment, all the symptoms were graded again.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\* Clinical diagnosis of hypertensive bradyarhhythmia\n\nExclusion Criteria:\n\n* With other elementary diseases\n* With pregnant\n* With receiving other treatment within past half year from the beginning of trial.'}, 'identificationModule': {'nctId': 'NCT04505228', 'briefTitle': 'The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia', 'organization': {'class': 'OTHER', 'fullName': 'Macrohard Institute of Health'}, 'officialTitle': 'The Personalized Chinese Herb Formulas Are Evaluated for Their Effectiveness to Relieve Symptoms in Hypertensive Bradyarrhythmia', 'orgStudyIdInfo': {'id': 'qdms17337nsh'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Research group', 'description': 'The patients receiving Atropine and the extra Chinese herb formulas treatment', 'interventionNames': ['Drug: Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy', 'Drug: Atropine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The patients receiving the basic treatment of atropine', 'interventionNames': ['Drug: Atropine Sulfate']}], 'interventions': [{'name': 'Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy', 'type': 'DRUG', 'otherNames': ['Xuefuzhuyu'], 'description': 'The designed Chinese herb formulas', 'armGroupLabels': ['Research group']}, {'name': 'Atropine Sulfate', 'type': 'DRUG', 'description': 'The basic treatment for heart disease', 'armGroupLabels': ['Control group', 'Research group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266000', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': "The fifth Qingdao people's hospital", 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jun Xiao', 'class': 'OTHER'}, 'collaborators': [{'name': "Qingdao Fifth People's Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jun Xiao', 'investigatorAffiliation': 'Macrohard Institute of Health'}}}}