Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-01 @ 4:00 AM
Study NCT ID:
NCT04046393
Status:
UNKNOWN
Last Update Posted:
2020-06-22
First Post:
2019-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D012852', 'term': 'Sinusitis'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-02-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-18', 'studyFirstSubmitDate': '2019-08-05', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WHOQOL-brief score (Taiwan version)', 'timeFrame': 'one month', 'description': 'consisting of 28 items, each scored from 1 to 5; total score recorded as the sum of all items change from baseline: the questionnaires of quality of life'}], 'secondaryOutcomes': [{'measure': '22-item Sino-Nasal Outcome Test score (SNOT-22)', 'timeFrame': 'one month', 'description': 'consisting of 22 items, each scored from 0 to 5; total score recorded as the sum of all items, 0 to 110 change from baseline: the questionnaires of chronic sinusitis severity'}, {'measure': 'Total symptom score(TSS）', 'timeFrame': 'one month', 'description': 'consisting of 4 items, each scored from 0 to 3; total score recorded as the sum of all items, 0 to 12 change from baseline: the questionnaires of chronic rhinitis severity'}, {'measure': 'Autonomic nerve (HRV)', 'timeFrame': 'one month', 'description': 'Low frequency (ms2), High frequency (ms2), LF/HF(indicate autonomic function) change from baseline'}, {'measure': 'Meridian energy', 'timeFrame': 'one month', 'description': 'Yang energy and Yin energy change from baseline'}, {'measure': 'Posttreatment culture negativity', 'timeFrame': 'one month', 'description': 'negative" means if no bacterial pathogen is identified on posttreatment culture but at least one has been present on pretreatment culture'}, {'measure': 'Nasopharyngoscopic examination change', 'timeFrame': 'one month', 'description': 'consisting of 3 items, each scored from 0 to 2; total score recorded as the sum of both side all items, 0 to 12 change from baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rhinitis, sinusitis, nasal irrigation, TCM'], 'conditions': ['Nasal Disease']}, 'descriptionModule': {'briefSummary': 'This study investigate the nasal irrigation with Traditional herbal medicine extract-saline isotonic solution in the treatment of chronic rhinitis and sinusitis. Half of participants will receive Traditional herbal medicine extract-saline isotonic solution nasal irrigation, while the other half will receive saline alone nasal irrigation.', 'detailedDescription': 'In the program, the investigators plan to investigate a clinical triad to research the outcomes of nasal irrigation with Traditional herbal medicine extract-saline isotonic solution for treatment of chronic rhinitis and sinusitis. The aims of this study are listed below:\n\nAim 1: evaluating the outcomes and quality of life of nasal irrigation with Traditional herbal medicine extract-saline isotonic solution to treat enrolled patients with chronic rhinitis or sinusitis. The investigators use modern devices to evaluate the autonomic nerve, meridian energy and pulse. The questionnaires of quality of life and symptoms will be recorded. Nasal irrigation with saline alone will be conducted during the clinical triad to compare the effectiveness and quality of life with Traditional herbal medicine extract.\n\nAim 2: analyzing the changes of bacteria culture in nasal discharge collected during the clinical triad before and after nasal irrigation for investigating the microenvironment of Traditional herbal medicine extract-saline isotonic solution.\n\nAccording to the research, the investigators will realize the improvement of using Traditional herbal medicine extract-saline isotonic solution for nasal irrigation to treat sino-nasal diseases, by investigating the changes of quality of life and microenvironment of nasal cavity. The nasopharyngoscopic examination, autonomic nerve, meridian energy and pulse were record to compare the effectiveness of Traditional herbal medicine extract-saline isotonic solution with nasal irrigation with saline alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnostic criteria for chronic rhinitis and sinusitis male and female volunteers.\n2. Stop using oral and topical steroid and anti-histamine treatments \\>2 weeks prior to enrollment.\n3. \\>20 years of age.\n\nExclusion Criteria:\n\n1. Allergy to herbal medicine.\n2. Presence of a sinus tumor.\n3. Significant immune dysfunction.\n4. Pregnancy and breast-feeding women.\n5. Undergone nasal surgery \\<1 week prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT04046393', 'briefTitle': 'Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Chia Yi Chang Gung Memorial Hospital', 'orgStudyIdInfo': {'id': '201801970A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Traditional Chinese Medicine(TCM) group', 'description': 'nasal irrigation with Traditional herbal medicine(licorice) extract-saline isotonic solution', 'interventionNames': ['Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411', 'Device: Meridian Energy Analysis Device(MEAD)', 'Procedure: bacteria culture', 'Procedure: nasopharyngoscopic examination', 'Combination Product: TCM nasal irrigation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline control group', 'description': 'nasal irrigation with saline isotonic solution', 'interventionNames': ['Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411', 'Device: Meridian Energy Analysis Device(MEAD)', 'Procedure: bacteria culture', 'Procedure: nasopharyngoscopic examination']}], 'interventions': [{'name': 'Taiwan Scientific" noninvasive blood pressure meter TS-0411', 'type': 'DEVICE', 'description': 'measure autonomic nerve', 'armGroupLabels': ['Saline control group', 'Traditional Chinese Medicine(TCM) group']}, {'name': 'Meridian Energy Analysis Device(MEAD)', 'type': 'DEVICE', 'description': 'measure meridian energy', 'armGroupLabels': ['Saline control group', 'Traditional Chinese Medicine(TCM) group']}, {'name': 'bacteria culture', 'type': 'PROCEDURE', 'description': 'use culture swab to culture nasal discharge', 'armGroupLabels': ['Saline control group', 'Traditional Chinese Medicine(TCM) group']}, {'name': 'nasopharyngoscopic examination', 'type': 'PROCEDURE', 'description': 'use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system', 'armGroupLabels': ['Saline control group', 'Traditional Chinese Medicine(TCM) group']}, {'name': 'TCM nasal irrigation', 'type': 'COMBINATION_PRODUCT', 'description': 'Chinese herbal medicine (licorice) extract solution with buffered salt packet and water in rinse bottle', 'armGroupLabels': ['Traditional Chinese Medicine(TCM) group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiayi City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Pei-Rung Yang', 'role': 'CONTACT', 'phone': '+886-5-3621000', 'phoneExt': '2069'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}], 'centralContacts': [{'name': 'Pei-Rung Yang', 'role': 'CONTACT', 'email': 'pamela750211@hotmail.com', 'phone': '+886-5-3621000', 'phoneExt': '2069'}], 'overallOfficials': [{'name': 'Pei-Rung Yang', 'role': 'STUDY_CHAIR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}