Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-28 @ 9:45 AM
Study NCT ID:
NCT04947761
Status:
UNKNOWN
Last Update Posted:
2021-09-05
First Post:
2021-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Tian Wang Bu Xin Dan Hydrogel Patch in Preventing Postoperative Delirium in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM)', 'timeFrame': 'Day 1 postoperatively', 'description': 'Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily'}, {'measure': 'Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM)', 'timeFrame': 'Day 2 postoperatively', 'description': 'Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily'}, {'measure': 'Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM)', 'timeFrame': 'Day 3 postoperatively', 'description': 'Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily'}], 'secondaryOutcomes': [{'measure': 'Sleep Quality', 'timeFrame': 'Baseline and 1,3 days after surgery', 'description': 'Objective sleep quality will be measured using a Fitbit Charge 3 activity monitor to be worn'}, {'measure': 'Athens Insomnia Scale', 'timeFrame': 'Baseline and 1,2,3 days after surgery', 'description': 'using the Athens Insomnia Scale to test the subjective sleep quality of patients. The range were from 0-3. Total score \\< 4 means sleep well; total score =6 means suspicious of insomnia; total score \\> 6 means insomnia.'}, {'measure': 'Pain at rest using Numerical Rating Scale(NRS)', 'timeFrame': 'postoperative days 1, 2, 3', 'description': 'NRS pain scores will also be measured at rest. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible).'}, {'measure': 'Total postoperative analgesic requirements', 'timeFrame': 'First 48 hours postoperatively', 'description': 'Amount of opioid (IV morphine or hydromorphone) and oral analgesics required for pain control, reported as overall morphine equivalents.'}, {'measure': 'Change in biological markers (1)', 'timeFrame': 'Baseline and 1 day after surgery', 'description': 'Plasma levels of CXCL13'}, {'measure': 'Change in biological markers (2)', 'timeFrame': 'Baseline and 1 day after surgery', 'description': 'Plasma levels of S100B'}, {'measure': 'STOP-Bang score', 'timeFrame': 'Baseline', 'description': 'STOP-BANG questionnaire'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline and day 3 postoperatively', 'description': 'The PSQI is filled out by the patient and assesses patient sleep quality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Delirium']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether preoperative administration of Modified Tian Wang Bu Xin Dan Hydrogel Patch prevents the incidence of postoperative delirium in elderly patients undergoing major surgery.', 'detailedDescription': "The Traditional Chinese Medicine (TCM) Tian Wang Bu Xin Dan (TWBXD, Cheonwangbosimdan), first recorded in Effective Formulae Handed Down for Generations ( Shi Yi De Xiao Fang) in 1337, is a herbal medicine that has been continuously utilized in Chinese medicine. It alleviates insomnia, anxiety, and palpitation by furnishing energy and stabilizing patients' mind. Cheonwangbosimdan can mitigate primary insomnia and secondary insomnia in patients with hyperthyroidism and menopause without severe side effects.\n\nTianwang Buxin Decoction has the same effect as Olanzapine for the treatment of delirium after hip joint replacement in falling-induced senile femoral neck fracture patients.\n\nThis study aim to evaluate the incidence of postoperative delirium in elderly patients treated with prophylactic Modified Cheonwangbosimdan Hydrogel Patch versus placebo patch."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients' age ≥70 years;\n2. Underwent elective non-cardiac surgery (including Orthopedics, thoracic, urology, general surgery patients)under general anesthesia ;\n\nExclusion Criteria:\n\n1. History of neuropsychiatric diseases including delirium, mental disorders, Parkinson, dementia, etc.;\n2. The operation was cancelled due to various reasons after the patient was enrolled;\n3. severe liver disease; severe renal dysfunction defined as either having creatinine clearance \\< 30 ml/min or being dialysis-dependent;\n4. Patients who undergo second operation in a short period;\n5. Past 30-day prescribed use of sedative-hypnotics for the indication of insomnia;\n6. History of alcohol abuse or a history of drug dependence;\n7. Cannot with the completion of tests of cognitive function;\n8. Known allergy to skin patch;\n9. Treatment site has active skin lesion or inflammation;\n10. Refused to participate in the study."}, 'identificationModule': {'nctId': 'NCT04947761', 'briefTitle': 'Modified Tian Wang Bu Xin Dan Hydrogel Patch in Preventing Postoperative Delirium in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Modified Tian Wang Bu Xin Dan Hydrogel Patch in Preventing Postoperative Delirium in Elderly Patients: A Muticenter Randomised Control Trial', 'orgStudyIdInfo': {'id': 'TWBXDPOD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'modified Cheonwangbosimdan Hydrogel patch', 'description': 'Group receiving modified Cheonwangbosimdan Hydrogel patch', 'interventionNames': ['Drug: modified Tian Wang Bu Xin Dan hydrogel patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo patch', 'description': 'Group receiving placebo patch', 'interventionNames': ['Other: placebo patch']}], 'interventions': [{'name': 'modified Tian Wang Bu Xin Dan hydrogel patch', 'type': 'DRUG', 'otherNames': ['modified Cheonwangbosimdan hydrogel patch'], 'description': 'modified Cheonwangbosimdan hydrogel patch (one patch/24 hours) applied to Shenque point for 4 days (1 patch daily beginning 2 days preoperative, and continued at 1 patch daily until 2 days postoperatively)', 'armGroupLabels': ['modified Cheonwangbosimdan Hydrogel patch']}, {'name': 'placebo patch', 'type': 'OTHER', 'description': 'placebo patch (one patch/24 hours) applied to Shenque point for 4 days (1 patch daily beginning 2 days preoperative, and continued at 1 patch daily until 2 days postoperatively)', 'armGroupLabels': ['Placebo patch']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingqun Yu, PhD', 'role': 'CONTACT', 'email': 'yuyingqun@sohu.com', 'phone': '8613521558519'}], 'facility': 'Fifth Medical center of Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weidong Mi, PhD', 'role': 'CONTACT', 'email': 'wwdd1962@aliyun.com', 'phone': '+8613381082966'}], 'facility': 'First Medical center of Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mengmeng Li, PhD', 'role': 'CONTACT', 'email': 'mmli304@163.com', 'phone': '8613401000778'}], 'facility': 'Fourth Medical center of Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Weidong Mi, PhD', 'role': 'CONTACT', 'email': 'wwdd1962@aliyun.com', 'phone': '8613381082966'}, {'name': 'Chunlei Ouyang, PhD', 'role': 'CONTACT', 'email': 'ouyangchunlei@gmail.com', 'phone': '+8618810300815'}], 'overallOfficials': [{'name': 'Weidong Mi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director (Cheif expert of National key research and development program of China 2018YFC2001900)', 'investigatorFullName': 'Weidong Mi', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}