Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-02-13 @ 2:28 PM
Study NCT ID:
NCT01904695
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2013-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'C563514', 'term': 'Hypertension Resistant to Conventional Therapy'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000959', 'term': 'Antihypertensive Agents'}, {'id': 'D049993', 'term': 'Sodium Chloride Symporter Inhibitors'}, {'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}], 'ancestors': [{'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D004232', 'term': 'Diuretics'}, {'id': 'D045283', 'term': 'Natriuretic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-04', 'studyFirstSubmitDate': '2013-07-14', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Possible side effects and adverse reactions', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, 8 weeks during treatment and 24 weeks follow-up', 'description': 'Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded'}], 'primaryOutcomes': [{'measure': 'Systolic (SBP) and diastolic (DBP) blood pressure reductions', 'timeFrame': 'Before treatment, 8 weeks during treatment'}], 'secondaryOutcomes': [{'measure': 'Cardiac event', 'timeFrame': 'Before treatment, 24 weeks follow-up'}, {'measure': 'Death incident', 'timeFrame': 'Before treatment, 24 weeks follow-up'}, {'measure': 'Scores for symptoms and signs', 'timeFrame': 'Before treatment, 8 weeks during treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['resistant hypertension', 'causal inference', 'a chorot study', 'recipe of removing both phlegm and blood stasis'], 'conditions': ['Primary Hypertension', 'Hypertension, Resistant to Conventional Therapy']}, 'referencesModule': {'references': [{'pmid': '25797643', 'type': 'BACKGROUND', 'citation': 'Yuwen Y, Liu YQ, Wang YP, Dai JG, Liu DS, Wang YX, Han XJ. The add-on effect of a Chinese herbal formula for patients with resistant hypertension: study protocol for a pilot cohort study. J Integr Med. 2015 Mar;13(2):122-8. doi: 10.1016/S2095-4964(15)60162-5.'}]}, 'descriptionModule': {'briefSummary': 'The research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment, the research takes the Resistant Hypertension (RH) as example to study the causal inference methods under real world.', 'detailedDescription': "Background: Syndrome differentiation is one of the substantial characteristics in Traditional Chinese Medicine (TCM) but is still lack of scientific evidence.The inference methods of causal relationship between treatment and clinial effect under real-word study may help.\n\nObjectives: This study aims to assess the efficacy of Phlegm and Stasis Syndrome differentiation method in treating resistant hypertension and explore causal inference in the real-world study.\n\nResearch design and methods: It is a multi-center,prospective,two-arm,cohort study including 200 patients with resistant hypertension (doctors' diagnosis based on the American Heart Association criteria 2008).Essential hypertension subjects,aged 18-70 years,blood pressure \\>140/90mmHg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.Thiazide diuretics and/or two more antihypertensive agents for 8 weeks, Chinese herbs (for synchronic treating phlegm and blood stasis) and nonpharmacological recommendations were initiated in the observational group and the control group received the same interventions without Chinese herbs.\n\nOutcome measures: The primary outcomes will be Systolic (SBP) and Diastolic (DBP) blood pressure reductions and changes in symptoms and signs.Cardiac event and death incident will be the secondary outcomes.Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded.\n\nDiscussion: This is a rigorous methodology pilot study and 200 patients are enough to calculate sample size in later formal trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Essential hypertension subjects, aged 18-70 years, blood pressure \\> 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.\n\nExclusion Criteria:\n\n* Patients will be excluded for the following conditions: with secondary resistant hypertension because of other disease like renal disease or pheochromocytoma; included in other clinical trial in one month; pregnant or breast-feed or preparing for pregnancy female; combined with disease like stroke, coronary atherosclerotic heart disease, diabetes, chronic renal failure or mental disease.'}, 'identificationModule': {'nctId': 'NCT01904695', 'briefTitle': 'Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'China Academy of Chinese Medical Sciences'}, 'officialTitle': 'Causal Inference Research of Resistant Hypertension Treatment With Recipe of Removing Both Phlegm and Blood Stasis in a Real World Study', 'orgStudyIdInfo': {'id': '81202846'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antihypertensive drugs & Herbs', 'description': 'Thiazide diuretics and ACE inhibitor and β-blocker \\& Herbs for 8 weeks', 'interventionNames': ['Drug: Herbs', 'Drug: Antihypertensive drugs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antihypertensive drugs', 'description': 'Thiazide diuretics and ACE inhibitor and β-blocker for 8 weeks', 'interventionNames': ['Drug: Antihypertensive drugs']}], 'interventions': [{'name': 'Herbs', 'type': 'DRUG', 'otherNames': ['recipe of removing both phlegem and blood stasis'], 'description': 'Herbs 180ml by mouth every 12 hours for 8 weeks', 'armGroupLabels': ['Antihypertensive drugs & Herbs']}, {'name': 'Antihypertensive drugs', 'type': 'DRUG', 'otherNames': ['Thiazide diuretics and ACE inhibitor and β-blocker'], 'description': 'Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks', 'armGroupLabels': ['Antihypertensive drugs', 'Antihypertensive drugs & Herbs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100700', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Ya YUWEN, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'China Academy of Chinese Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Ya YUWEN', 'investigatorAffiliation': 'China Academy of Chinese Medical Sciences'}}}}