Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-02-02 @ 12:18 PM
Study NCT ID:
NCT05318859
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2022-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety of Pharmacopuncture on Musculoskeletal Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2022-02-11', 'studyFirstSubmitQcDate': '2022-04-01', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of infection cases', 'timeFrame': '1 month', 'description': 'Infection is one of the representative adverse events for subcutaneous and intramuscular interventions. Infection cases will be collected to evaluate the safety of pharmacopuncture.'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'during admission (from day 2 to until discharge), 1 month', 'description': 'Adverse events refers to undesirable and unintended signs (eg, abnormalities in laboratory test values), symptoms, or diseases that appear after a procedure in the course of a clinical study. Any reported adverse events will be collected to evaluate the safety of pharmacopuncture.'}, {'measure': 'Number of abnormal cases that appeared on the blood analysis', 'timeFrame': 'Day 2, discharge day, 1 month', 'description': 'Any blood analysis result including liver function and renal function will be measured at admission day and discharge moment. The researcher records every abnormal result cases that appeared on the blood analysis and number of abnormal cases will be counted, to evaluate the safety of pharmacopuncture.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal joint', 'Safety', 'Pharmacopuncture', 'Adverse Event'], 'conditions': ['Musculoskeletal Diseases or Conditions', 'Spine; Arthrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of pharmacopuncture by observing any adverse events that may occur after pharmacopuncture treatment in with spinal joint disease hospitalized patients at 7 Korean medicine hospitals and analyzing blood test results.', 'detailedDescription': 'This study was an registry observational study, and was conducted in 7 Korean medicine hospitals (160 patients at Jaseng Korean medicine Hospital, 140 patients at Daejeon Jaseng Hospital of Korean Medicine, 140 patients at Bucheon Jaseng Hospital of Korean Medicine, 140 patients at Haeundae Jaseng Korean medicine Hospital, 140 patients at Kyunghee University of Korean medicine Hospital, 140 patients at Kyung Hee University of Korean Medicine Hospital at Gangdong, and 140 patients at Dongguk University Bundang Oriental Hospital).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients with diagnosed spinal joint disease who are admitted or scheduled to be admitted to Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, or Haeundae Jaseng Hospital of Korean Medicine, Kyung Hee University Korean Medicine Hospital at Gangdong, Kyung Hee University Korean Medicine Hospital, Dongguk Traditional Herbal Medicine Clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients with diagnosed spinal joint disease\n* Patients who received pharmacopuncture treatment during hospitalization\n* Patients who are 19 years of age or older and less than 70 years old\n* Patients who agreed to participate in the clinical study and voluntarily given written informed consent\n\nExclusion Criteria:\n\n* Patients with difficulty or refusal to give sign written informed consent\n* Patients for whom the researchers judge participation in the clinical study to be difficult'}, 'identificationModule': {'nctId': 'NCT05318859', 'briefTitle': 'The Safety of Pharmacopuncture on Musculoskeletal Patients', 'organization': {'class': 'OTHER', 'fullName': 'Jaseng Medical Foundation'}, 'officialTitle': 'The Safety Assessment of Pharmacopuncture on Musculoskeletal Patients: a Multi-center, Registry', 'orgStudyIdInfo': {'id': 'JS-CT-2021-17'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pharmacopuncture', 'type': 'OTHER', 'description': 'Registry (observational study)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35262', 'city': 'Daejeon', 'state': 'Daejeon', 'country': 'South Korea', 'facility': 'Daejeon Jaseng Hospital of Korean Medicine', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '135-896', 'city': 'Seoul', 'state': 'Gangnam-Gu', 'country': 'South Korea', 'facility': 'Jaseng Hospital of Korean Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '14598', 'city': 'Bucheon-si', 'state': 'Gyeonggi Province', 'country': 'South Korea', 'facility': 'Bucheon Jaseng Hospital of Korean Medicine', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Haeundae Jaseng Hospital of Korean Medicine', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '02447', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Korean Medicine Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05278', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '13601', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Dongguk University Bundang Oriental Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'In-Hyuk Ha, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jaseng Medical Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaseng Medical Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hospital director, Research director', 'investigatorFullName': 'In-Hyuk Ha, KMD', 'investigatorAffiliation': 'Jaseng Medical Foundation'}}}}