Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04702659
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2021-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chinese Medicine Zhengyi Prescription Tea Bag
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-15', 'studyFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2021-01-08', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'questionnaire-the Chinese Version of the 31-Item Rhinosinusitis Outcome Measure', 'timeFrame': '28days', 'description': "The questionnaire contains a total of 31 assessment items:\n\nDivided into 7 major aspects: nasal symptoms (6 questions), eye symptoms (2 questions), Sleep condition (4 questions), ear symptoms (5 questions), overall symptoms (7 questions), daily life Influence (4 questions) and the influence of emotions (3 questions). According to the patient's four weeks,the symptoms within are scored for each item, and the first category is to evaluate the symptoms of this item. The first score ranges from 0 points (no such symptoms) to 5 points (extremely severe Heavy); The second category is to assess the importance of this symptom to the patient, starting from 1 Points (not important) to 4 points (very important). Multiply these two fractions together to get the symptom-impact score , this is the individual evaluation score of each patient for each symptom."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Herbal Interaction']}, 'descriptionModule': {'briefSummary': "Chinese herbal tea bags can adjust physiological functions, help protect power, and give positive energy to the body. This prescription not only focuses on regulating the patient's physical function, but also helps to enhance physical strength.", 'detailedDescription': 'In Taiwan ,acoording to the TCM theories and viewpoints, Chinese herbal medicine plays an important role in clinical drug application.TCM compound combinations for different diseases, emphasizing the complementarity and balance of ingredients, natural gentleness, uniqueness and efficacy are widely accepted by the public.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants have no chronic respiratory disease or those who have been diagnosed as nasal and sinusitis by a doctor, whose clinical diagnosis includes subjects with allergic rhinitis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over the age of 20, those who have no chronic respiratory disease or those who have been diagnosed as nasal and sinusitis by a doctor, whose clinical diagnosis includes subjects with allergic rhinitis.\n\nExclusion Criteria:\n\n1. Patient characteristics: age, gender, weight, education level, race, pregnancy and breastfeeding status, smoking, drinking, caffeine, alcohol or drug poisoning, diet and nutritional status, physical limitations, genetic history, etc. Exclude women under the age of 20, unable to order their behavior, pregnant or breast-feeding women\n2. Disease characteristics: Subjects who have been diagnosis of mental illness by doctors, as well as long-term diarrhea or long-term use of Chinese medicine.\n3. Environmental characteristics: other conditions that make patients unable to cooperate. Such as unsuitability after screening, not signing the subject consent form, etc.'}, 'identificationModule': {'nctId': 'NCT04702659', 'briefTitle': 'Chinese Medicine Zhengyi Prescription Tea Bag', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'The Study of Clinical Observation About Chinese Medicine Zhengyi Prescription', 'orgStudyIdInfo': {'id': '2020-10-002B'}}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Center for Traditional Medicine, Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'chang kaiwei, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TaipeiVGH Center for Traditional Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}