Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-22 @ 1:50 PM
Study NCT ID:
NCT02319603
Status:
UNKNOWN
Last Update Posted:
2015-07-23
First Post:
2014-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of Wenxin Keli in Treating Atrial Premature Beats
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018880', 'term': 'Atrial Premature Complexes'}], 'ancestors': [{'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C532373', 'term': 'wenxin keli'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 288}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-22', 'studyFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2014-12-14', 'lastUpdatePostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 h dynamic electrocardiogram (Holter)', 'timeFrame': 'Baseline, up to 4 weeks, each record at a time.', 'description': 'Baseline, up to 4 weeks, each record at a time.'}], 'secondaryOutcomes': [{'measure': 'Symptom scores', 'timeFrame': 'Baseline, up to 4 weeks, each record at a time.', 'description': 'Baseline, up to 4 weeks, each record at a time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Premature Beats']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing clinical trial，to evaluate the efficacy and safety of Wenxin keli in treating atrial premature beats by different dose,to provide a scientific basis for rational clinical use of drug.', 'detailedDescription': 'Research purpose： To evaluate the efficacy and safety of Wenxin keli in treating atrial premature beats by different dose,to provide a scientific basis for rational clinical use of drug.\n\nResearch design： A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing clinical trial.\n\nSample size:\n\nA total of 288 subjects, 144cases in each group.\n\nTherapeutic schedule:\n\n1. Low dose group (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g.\n2. High dose group(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g.\n\nUsage and Dosage:\n\nOral ,1bag each time, 3 times a day, 4 weeks for 1 course of treatment.\n\nDrug combination:\n\nDuring the test shall not merge the other anti-arrhythmic drugs beyond the provisions of this scheme. Due to merger disease or condition changes ,have to use drugs or other treatment, investigators must record the types (or other treatment ),drug usage, time and reasons, in order to summarize ,analyze and report.\n\nPrimary indicator:\n\n24 h dynamic electrocardiogram (Holter): before treatment, after treatment of 4 w, each record at a time.\n\nSecondary Indicator:\n\nSymptom scores: before treatment, after treatment of 4 w, each record at a time.\n\nSecurity index:\n\n1. Vital signs: before treatment, after treatment of 4 w, each record at a time.\n2. Blood, urine, stool occult blood ,liver and kidney function, blood coagulation four, electrolyte examination, electrocardiogram(ecg): before treatment, after treatment of 4 w, each record at a time.\n\nMain efficacy:\n\nHolter efficient curative effect (main efficacy index) Effective: premature beat frequency reduced 50% or more before taking the medicine.\n\nInvalid: no effective standard.\n\nSecondary efficacy:\n\nSymptom scores curative effect Effective:symptoms improve symptoms(drop 1or above) Invalid: no effective standard.\n\nStatistic analysis:\n\nMain efficacy index by means of FAS,PPS analysis ,safety index SS set analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Accord with the diagnostic criteria of arrhythmia (atrial premature beats )\n* The average number of premature beat of 24 h dynamic electrocardiogram \\>360 times/h (effective record at least 22 h)\n* Stop using the anti- arrhythmic drugs for more than five half-life (except that who long-term (one month or more) with beta blockers for high blood pressure and exertional angina)\n* Ages 18 to 75 years old ,all genders\n* Voluntary subjects and signed the informed consent form\n\nExclusion Criteria:\n\n* Need to merge other anti-arrhythmic drugs(Ⅰ,Ⅱ,Ⅲ,Ⅳ) for serious condition\n* Heart rhythm disorders caused by the factors such as drugs ,electrolyte and acid-base balance disorders\n* Merge tardy arrhythmia (including sick sinus syndrome and Ⅱdegree atrioventricular block)\n* Patients have had heart percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) surgery\n* Patients with severe hypotension\n* With serious cardiovascular diseases (severe coronary heart disease, congenital heart disease, cardiomyopathy, myocardial infarction, congestive heart failure, cardiac shock, etc.), cerebrovascular disease, severe respiratory diseases (chronic obstructive pulmonary disease, pulmonary hypertension, pulmonary embolism, etc.),serious primary diseases such as liver, kidney and hematopoietic system (ALT,AST,BUN 2 times higher than normal ceiling, or Cr higher than the upper limit of normal)\n* Allergic constitution; the test drug allergy or its ingredients or elements allergy\n* Pregnancy and lactation women ,recent preparation pregnancy\n* With chronic alcoholism , drug dependence, mental illness\n* Participated in other clinical trials within 3 months\n* Patients thought by the investigators not suitable to participate in clinical trials'}, 'identificationModule': {'nctId': 'NCT02319603', 'briefTitle': 'To Evaluate the Efficacy and Safety of Wenxin Keli in Treating Atrial Premature Beats', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Bozhiyin T&S Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Two Dose Group, Parallel-control Multi-center, Post-marketing Clinical Trial,to Evaluate the Efficacy and Safety of Wenxin Keli in Treating Atrial Premature Beats.', 'orgStudyIdInfo': {'id': 'WX-20141022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose WenXin keli', 'description': 'Low dose group (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g.\n\nOral ,1 bag each time, 3 times a day, 4 weeks for 1 course of treatment.', 'interventionNames': ['Drug: Low dose WenXin keli']}, {'type': 'EXPERIMENTAL', 'label': 'High dose WenXin keli', 'description': 'High dose group(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g.\n\nOral ,1 bag each time, 3 times a day, 4 weeks for 1 course of treatment.', 'interventionNames': ['Drug: High dose WenXin keli']}], 'interventions': [{'name': 'Low dose WenXin keli', 'type': 'DRUG', 'otherNames': ['the original quantity Wenxin keli'], 'description': 'Low dose WenXin keli (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g.', 'armGroupLabels': ['Low dose WenXin keli']}, {'name': 'High dose WenXin keli', 'type': 'DRUG', 'otherNames': ['2 times the amount of Wenxin keli'], 'description': 'High dose WenXin keli(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g.', 'armGroupLabels': ['High dose WenXin keli']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'duan jingbo, visiting staff', 'role': 'CONTACT', 'email': 'duanjiangbopku@126.com', 'phone': '18612189012'}], 'facility': "Peking University people's hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jihong Guo, doctor', 'role': 'CONTACT', 'phone': '13901148380'}, {'name': 'Jingbo Duan', 'role': 'CONTACT', 'email': 'duanjiangbo@gmail.com', 'phone': '18612189012'}], 'overallOfficials': [{'name': 'Jihong Guo, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director of department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Bozhiyin T&S Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}