Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-22 @ 11:11 PM
Study NCT ID:
NCT02533635
Status:
UNKNOWN
Last Update Posted:
2015-08-27
First Post:
2015-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ganoderma Tea on Eczema Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2015-08-18', 'studyFirstSubmitQcDate': '2015-08-24', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Oriented Eczema Measure', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Eczema Area and Severity Index', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Eczema']}, 'descriptionModule': {'briefSummary': 'This is a single-blind, cross-over pilot study to observe the safety and efficacy of Ganoderma tea on eczema patients.', 'detailedDescription': 'Objective This study is to conduct a preliminary observation on the effect of A Master Ganoderma Detox Tea in improving eczema symptoms. Because it is a preliminary study, there will not be a placebo control. However, in order to exclude the impact of spontaneous improvement, we will set up a cross over control group. Thus, we want to find out whether there is any difference in taking the tea and without taking the tea.\n\nResearch Design This is a randomized, cross-over-control and assessor-blinded clinical trial. Subjects will be divided into groups A and group B. Group A will receive the intervention for 8 weeks, followed by an 8-week period of no intervention. Group B will be observed without having any intervention for 8 weeks, and then receive the intervention for 8 weeks. Randomization will be carried out using a computer program.\n\nInterventions Subjects in the treatment group (A) will take the A Master Ganoderma Detox Tea for 8 weeks. Initially, the dosage is twice a day, one pack (5g) each time, and then increased to three times a day, two packs each time within two weeks. The control group (B) will not receive any study intervention for 8 weeks, followed by similar intervention for 8 weeks.\n\nIn case of allergies or severe adverse reactions occur, the subject should stop taking the tea immediately and be excluded from the trial. During the control or intervention period, if necessary, subject may use short-term steroids or other topical medication to relieve the symptoms of eczema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* eczema for 1 year, without other systemic illness.\n\nExclusion Criteria:\n\n* severe systemic illness,\n* oral steroid in the last month'}, 'identificationModule': {'nctId': 'NCT02533635', 'briefTitle': 'Ganoderma Tea on Eczema Patient', 'organization': {'class': 'OTHER', 'fullName': 'Hong Kong Baptist University'}, 'officialTitle': 'Product Functional Study of Effect A Master Ganoderma Detox Tea on Eczema Patient', 'orgStudyIdInfo': {'id': 'HongKongBU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A-first intervention', 'description': 'Subjects in Arm A receive Ganoderma tea (30g) daily for 8 weeks initially, followed by 8 weeks no intervention.', 'interventionNames': ['Dietary Supplement: A Master Ganoderma Detox Tea']}, {'type': 'EXPERIMENTAL', 'label': 'B-second intervention', 'description': 'Subjects in Arm B receive no intervention for 8 weeks initially, followed by receiving Ganoderma tea (30g) daily for 8 weeks .', 'interventionNames': ['Dietary Supplement: A Master Ganoderma Detox Tea']}], 'interventions': [{'name': 'A Master Ganoderma Detox Tea', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['老和尚靈芝健康茶（又名老和尚靈芝排毒茶）'], 'description': 'A Master Ganoderma Detox Tea is consisted of GANODERMA, HERBA HOUTTUYNIAE, GLYCYRRHIZAE RADIX ET RHIZOMA and RUCTUS MOMORDICAE.', 'armGroupLabels': ['A-first intervention', 'B-second intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Kowloon Tong', 'state': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Carol Leung, Master of TCM', 'role': 'CONTACT', 'email': '173661@hkbu.edu.hk', 'phone': '85234688878', 'phoneExt': '8878'}, {'name': 'Shi Ping Zhang, PhD', 'role': 'CONTACT', 'email': 'spzhang@hkbu.edu.hk', 'phone': '85234112466', 'phoneExt': '2466'}], 'facility': 'School of Chinese Medicine Building', 'geoPoint': {'lat': 22.33312, 'lon': 114.17969}}], 'centralContacts': [{'name': 'Shi Ping Zhang, PhD', 'role': 'CONTACT', 'email': 'spzhang@hkbu.edu.hk', 'phone': '85234112466', 'phoneExt': '2466'}, {'name': 'Carol Leung, BTCM', 'role': 'CONTACT', 'email': '173661@hkbu.edu.hk', 'phone': '85234688878', 'phoneExt': '8878'}], 'overallOfficials': [{'name': 'Shi Ping Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hong Kong Baptist University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Kong Baptist University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Shi Ping Zhang', 'investigatorAffiliation': 'Hong Kong Baptist University'}}}}