Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT05901532
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2023-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C022871', 'term': 'isoborneol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of rhinitis symptom score', 'timeFrame': 'Evaluated baseline and 2-month nasal lavage', 'description': 'The effect of rhinorrhea, sneezing, nasal obstruction and itching on life quality was measuring by scores. Score 0 means no symptom, score 1 means symptomatic but not annoying, score 2 means troublesome symptoms and affecting part of daily activity or sleep and score 3 means annoying symptoms and affecting most daily activity or sleep.'}, {'measure': 'Self-reported adverse events', 'timeFrame': 'Through study completion, an average of 2 months', 'description': 'Any adverse events occurring during the study period'}], 'secondaryOutcomes': [{'measure': 'Change of swollen degree of inferior turbinates', 'timeFrame': 'Evaluated baseline and 2-month nasal lavage', 'description': 'The swollen degree of inferior turbinates was measuring by scores. Score 0 means inferior turbinates occupying less than 25% of nasal cavity, score 1 means inferior turbinates occupying 26 to 50 of nasal cavity, score 2 means inferior turbinates occupying 51 to 75 of nasal cavity and score 3 means inferior turbinates occupying more than 75% of nasal cavity.'}, {'measure': 'Change of the second minimal cross-sectional area of the nasal cavity', 'timeFrame': 'Measured baseline and 2-month nasal lavage', 'description': 'The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.'}, {'measure': 'Change of total inspiratory resistance', 'timeFrame': 'Measured baseline and 2-month nasal lavage', 'description': 'Total inspiratory resistance was measured by rhinomanometry.'}, {'measure': 'Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire', 'timeFrame': 'Evaluated baseline and 2-month nasal lavage', 'description': 'Using a 7-item Eustachian Tube Dysfunction Patient Questionnaire to evaluate Eustachian Tube function'}, {'measure': 'Change of Eustachian Tube function test', 'timeFrame': 'Evaluated baseline and 2-month nasal lavage', 'description': 'Performing a Eustachian Tube Function Test to evaluate Eustachian Tube function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rhinitis, Allergic', 'Nasal Lavage', 'Medicine, Chinese Traditional'], 'conditions': ['Rhinitis, Allergic', 'Nasal Lavage', 'Medicine, Chinese Traditional']}, 'descriptionModule': {'briefSummary': 'In allergic rhinitis patients with severe symptoms, control of severe allergic reactions is limited with saline nasal irrigation. Therefore, there have been several attempts to use saline nasal irrigation in combination with other treatments to treat allergic rhinitis. This study tries to explore the effect of nasal irrigation with Chinese herbal medicines on allergic rhinitis.', 'detailedDescription': 'In this study, patients with allergic rhinitis over 20 years old were collected from the clinics of Otolaryngology and Traditional Chinese Medicine clinics. The subjects were randomly divided into two groups. They used the devices of NeiMed sinus rinse to irrigate the nose with 240 cc of Chinese herbal medicine solution or placebo each morning and evening for 2 months. Subjects in both groups filled questionnaires, and received acoustic rhinometry, rhinomanometry, and eustachian tube function tests before and after nasal irrigation. This study tries to explore the effect of nasal irrigation with Chinese herbal medicines on allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Allergic rhinitis patients diagnosed based on the history and allergen test\n\nExclusion Criteria:\n\n* Those younger than 20 years old, Immunocompromised patients Pregnant women or breastfeeding women Those with a history of allergy to traditional Chinese medicine Those with liver and kidney insufficiency Those who cannot cooperate with nasal irrigation'}, 'identificationModule': {'nctId': 'NCT05901532', 'briefTitle': 'Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis: Phase 2 Randomized, Double-blinded, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'CF19289A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chinese herbal medicine', 'description': 'The bilateral nasal cavity was irrigated with a bottle of NeilMed containing 1 gram of Szechwan Lovage Rhizome, 1 gram of Biod Magnolia Bud, 0.5 gram of Taiwan Angelica Root, 0.5 gram of Wild Mint Herb, 1.5 gram of Baikal Skullcap Root, and 0.5 gram of Borneol dissolved in 240 ml of warm normal saline once a day.', 'interventionNames': ['Drug: Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The bilateral nasal cavity was irrigated with a bottle of NeilMed containing edible caramel dissolved in 240 ml of warm normal saline once a day.', 'interventionNames': ['Drug: edible caramel']}], 'interventions': [{'name': 'Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol', 'type': 'DRUG', 'description': 'The bilateral nasal cavity was irrigated with a plastic bottle containing 1 gram of Szechwan Lovage Rhizome, 1 gram of Biod Magnolia Bud, 0.5 gram of Taiwan Angelica Root, 0.5 gram of Wild Mint Herb, 1.5 gram of Baikal Skullcap Root, and 0.5 gram of Borneol dissolved in 240 ml of warm normal saline once a day for 2 months.', 'armGroupLabels': ['Chinese herbal medicine']}, {'name': 'edible caramel', 'type': 'DRUG', 'description': 'The bilateral nasal cavity was irrigated with a plastic bottle containing edible caramel dissolved in 240 ml of warm normal saline once a day for 2 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Rong-San Jiang', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Rong-San Jiang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taichung Veterans General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}