Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT05833932
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Suhexiang Pill for Acute Ischemic Stroke: A Registry Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2023-03-24', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients independent', 'timeFrame': '90 days', 'description': 'Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2.'}], 'secondaryOutcomes': [{'measure': 'National Institute of Health Stroke Scale', 'timeFrame': 'The change from baseline to day 10 or discharge.', 'description': 'The National Institute of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurological deficits.'}, {'measure': 'Glasgow Coma Scale', 'timeFrame': 'The change from baseline to day 10 or discharge.', 'description': 'The Glasgow Coma Scale (GCS) is used to describe the extent of impaired consciousness in all types of acute medical and trauma patients, ranging from 0 to 15, with lower scores indicating more severe impaired consciousness.'}, {'measure': 'Patient reported outcome', 'timeFrame': 'At day 10 or discharge.', 'description': 'The patient reported outcome (PRO) scale of stroke consists of four dimensions including the influence on physical, emotional, and social functioning, as well as the overall satisfaction with treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute ischemic stroke', 'traditional Chinese medicine', 'registry study'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '39875901', 'type': 'DERIVED', 'citation': 'Lai X, Xiong X, Jia Q, Liu T, Yang Z, Zhang C, Kong L, Cao K, Dong T, Fang C, Ge J, Dong L, Zong Z, Chen S, Ma Y, Bai X, Wu D, Xie Y, Zhang M, Wang Y, Jiang G, Song D, Wang Y, Gui C, Geng Q, Gao Y; SUNRISE study investigators. Suhexiang pill for acute ischemic stroke in real-world practice setting (SUNRISE): protocol of a multicenter registry. BMC Complement Med Ther. 2025 Jan 28;25(1):30. doi: 10.1186/s12906-025-04762-9.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to investigate the effectiveness and safety of the Suhexiang Pill for patients with acute ischemic stroke in real-world settings.', 'detailedDescription': 'Suhexiang Pill, a traditional Chinese patent medicine, is widely used in China for acute stroke. However, there is a lack of evidence of its efficacy and safety for acute ischemic stroke in real-world setting. This registry study will recruit 1000 patients who receive Suhexiang Pill treatment after acute ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with Acute ischemic stroke.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute ischemic stroke within 7 days of symptom onset.\n* Age ≥ 18\n* Patient who has received Suhexiang Pill treatment\n* Patient or legally authorized representative has signed informed consent.\n\nExclusion Criteria:\n\n* Be allergic to Suhexiang Pill\n* Known to be pregnant or breastfeeding.\n* With conditions that render outcomes or follow-up unlikely to be assessed.'}, 'identificationModule': {'nctId': 'NCT05833932', 'acronym': 'SUNRISE', 'briefTitle': 'Suhexiang Pill for Acute Ischemic Stroke: A Registry Study', 'organization': {'class': 'OTHER', 'fullName': 'Dongzhimen Hospital, Beijing'}, 'officialTitle': 'Suhexiang Pill for Acute Ischemic Stroke: A Prospective Registry Study of Real-world Data', 'orgStudyIdInfo': {'id': '2021XS-001-05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Suhexiang Pill', 'type': 'DRUG', 'description': 'Suhexiang Pill is an approved traditional Chinese patent medicine.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100700', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinxing Lai, M.D.', 'role': 'CONTACT', 'email': 'new-star@163.com', 'phone': '15901111280'}], 'facility': 'Dongzhimen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100700', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinxing Lai, M.D.', 'role': 'CONTACT', 'email': 'new-star@163.com', 'phone': '08615901111280'}], 'facility': 'Dongzhimen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dongzhimen Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ying Gao', 'investigatorAffiliation': 'Dongzhimen Hospital, Beijing'}}}}