Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT03594656
Status:
UNKNOWN
Last Update Posted:
2021-08-26
First Post:
2018-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 288}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2018-07-11', 'lastUpdatePostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in UPDRS Part III subscores', 'timeFrame': '72 weeks', 'description': 'Compare changes in UPDRS part III scores from baseline to week 72 between early-start group and delayed-start group'}, {'measure': 'Changes in Schwab-England scores', 'timeFrame': '72 weeks', 'description': 'Compare changes in Schwab-England scores from baseline to week 72 between early-start group and delayed-start group'}, {'measure': 'Ratios of subjects in need of additional antiparkinsonian drugs', 'timeFrame': '72 weeks', 'description': 'Compare ratios of subjects in need of additional antiparkinsonian drugs during the 72 week period between early-start group and delayed-start group'}], 'secondaryOutcomes': [{'measure': 'Changes in ADAS-COG scores', 'timeFrame': '72 weeks', 'description': 'Compare changes in ADAS-COG scores from baseline to week 72 between early-start group and delayed-start group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Lingzhi', 'Traditional Chinese Medicine'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Lingzhi(Ganoderma) is widely used in traditional Chinese medicine. Previous studies indicated that Lingzhi was safe, well tolorated, and improved symptoms as an add-on therapy to levodopa in early Parkinson's disease(PD) patients. Here the investigators design a multicenter, randomized, double-blind, placebo-controlled, delayed-start trial to evaluate the effects of Lingzhi on modifying disease progression in untreated PD patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meeting the criteria for "Probable Parkinson\'s disease" according to 2015 MDS Clinical Diagnostic Criteria for Parkinson\'s Disease\n* Aged 30-80 years\n* Hoehn-Yahr Stageā¤2\n* UPDRS Part III subscores ranging from 10 to 30 points\n* Disease duration of 5 years or less\n* Untreated with antiparkinsonian drugs for at least two weeks preceding the trial\n* Willing to sign the written informed consent\n\nExclusion Criteria:\n\n* Atypical or secondary parkinsonism\n* With psychiatric symptoms or a history of psychiatric diseases\n* With cognitive impairment(MMSE score\\<24)\n* Major liver or kidney dysfunction\n* Participating in other clinical trials within 3 months preceding the current trial'}, 'identificationModule': {'nctId': 'NCT03594656', 'briefTitle': "Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': "Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial", 'orgStudyIdInfo': {'id': '2017YFC1310202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early-start Group', 'description': 'Receiving Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 72 weeks', 'interventionNames': ['Drug: Ganoderma']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Delayed-start Group', 'description': 'Receiving placebo for 24 weeks followed by Lingzhi (Ganoderma in capsule form) 0.8g twice daily for 48 weeks', 'interventionNames': ['Drug: Ganoderma', 'Drug: Placebos']}], 'interventions': [{'name': 'Ganoderma', 'type': 'DRUG', 'otherNames': ['Lingzhi'], 'description': '0.8g twice daily', 'armGroupLabels': ['Delayed-start Group', 'Early-start Group']}, {'name': 'Placebos', 'type': 'DRUG', 'description': '0.8g twice daily', 'armGroupLabels': ['Delayed-start Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Erhe Xu, M.D.', 'role': 'CONTACT', 'email': 'xuerhe@163.com', 'phone': '010-83198677'}], 'facility': 'Xuanwu Hospital of Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Erhe Xu, M.D.', 'role': 'CONTACT', 'email': 'xuerhe@163.com', 'phone': '010-83198677'}], 'overallOfficials': [{'name': 'Erhe Xu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital of Capital Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}