Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-22 @ 11:44 PM
Study NCT ID:
NCT05517993
Status:
UNKNOWN
Last Update Posted:
2022-08-26
First Post:
2022-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2022-08-24', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intradialytic hypotension episode', 'timeFrame': 'Each time of dialysis during 12-weeks study period.', 'description': 'Hypotension episode during hemodialysis'}], 'secondaryOutcomes': [{'measure': 'Early termination of hemodialysis', 'timeFrame': 'Each time of dialysis during 12-weeks study period.', 'description': 'The episode of early termination in hemodialysis due to hypotension'}, {'measure': 'SF-36', 'timeFrame': 'Baseline, 12 weeks, 28 weeks', 'description': 'Short Form (36) Health Survey (SF-36)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intradialytic Hypotension', 'Chinese herbal medicine', 'Gui-Lu-Er-Xian-Jiao'], 'conditions': ['Intradialytic Hypotension']}, 'descriptionModule': {'briefSummary': "Intradialytic hypotension (IDH), a common complication during hemodialysis (HD) could increase patients' morbidity and mortality. Previous studies considered that some Chinese herbal medicine (CHM) plays a complementary role in reducing the frequency of IDH. This trial is aimed to investigate the effect of Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) in patients with intradialytic hypotension."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End stage renal disease treated with hemodialysis for ≥3 months\n* Receive a standard thrice-weekly hemodialysis schedule\n* More than 25% of hemodialysis sessions complicated by intradialytic hypotension\n\nExclusion Criteria:\n\n* Active malignancy\n* Life-threatening conditions\n* Pregnancy\n* Recent participation in another clinical trial for intradialytic hypotension\n* History of hypersensitivity or contraindication to herbal medicine'}, 'identificationModule': {'nctId': 'NCT05517993', 'briefTitle': 'Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension: a Randomized Crossover Pilot Trial', 'orgStudyIdInfo': {'id': 'CMRPG8M0841'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) 3g orally twice daily for 12 weeks.', 'interventionNames': ['Drug: Gui-Lu-Er-Xian-Jiao-Wan']}, {'type': 'NO_INTERVENTION', 'label': 'Group B', 'description': 'No intervention.'}], 'interventions': [{'name': 'Gui-Lu-Er-Xian-Jiao-Wan', 'type': 'DRUG', 'otherNames': ['GLEXJW'], 'description': 'Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) is an ancient CHM formula, mainly originating from processed tortoise shells, antlers, Ginseng, and wolfberry.', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '833', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Chun-Ting Liu', 'role': 'CONTACT', 'email': 'juntin0214@gmail.com', 'phone': '+88677317123'}], 'overallOfficials': [{'name': 'Chun-Ting Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}