Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-01-16 @ 6:59 PM
Study NCT ID:
NCT00629161
Status:
UNKNOWN
Last Update Posted:
2010-05-28
First Post:
2008-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000277', 'term': 'Adjuvants, Pharmaceutic'}], 'ancestors': [{'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'lastUpdateSubmitDate': '2010-05-26', 'studyFirstSubmitDate': '2008-02-25', 'studyFirstSubmitQcDate': '2008-02-25', 'lastUpdatePostDateStruct': {'date': '2010-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale (UPDRS)", 'timeFrame': '13 months'}], 'secondaryOutcomes': [{'measure': 'Hoehn & Yahr scale', 'timeFrame': '13 months'}, {'measure': 'Schwab & England score', 'timeFrame': '13 months'}, {'measure': 'The liver kidney deficiency scale score by Traditional Chinese Medicine standard', 'timeFrame': '13 months'}, {'measure': 'Dose of levodopa per day', 'timeFrame': '13 months'}, {'measure': 'Dose of dopamine Agonists per day', 'timeFrame': '13 months'}, {'measure': 'Parkinson disease sleep scale (PDSS)', 'timeFrame': '13 months'}, {'measure': 'Assessment of autonomic dysfunction in Parkinson disease (SCOPA-AUT)', 'timeFrame': '13 months'}, {'measure': 'Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transaminase(ALT), aspartate transaminase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples, ect.', 'timeFrame': '12 months'}]}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of Traditional Chinese Medicinal Mixture in Parkinson's disease (PD) patients. The treatment phase includes 12 months period of Traditional Chinese Medicinal Mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.", 'detailedDescription': "The design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. The intervention includes Traditional Chinese Medicinal Mixture tid or matched placebo.\n\nParticipating study centers include Neurological University Outpatient Clinics and Neurological Departments of Community-based Hospitals experienced with PD patients.\n\nThe primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS).\n\nThe hypothesis of this study was that Traditional Chinese Medicinal Mixture improves the overall wellbeing of PD patients and thus may leads to an improvement of parkinsonian symptoms in PD patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's disease according to the UK Brain Bank criteria\n* Hoehn \\& Yahr stadium Ⅰ～Ⅲ\n* Age over 50 years\n* Taking only levodopa and/or dopamine agonists when recruiting\n* Consistent with the liver kidney deficiency type by Traditional Chinese Medicine (TCM) standard\n* Patients voluntarily take part in this study and signed the informed consent\n\nExclusion Criteria:\n\n* Modified Hoehn-Yahr scale are higher than 4\n* Had other serious illness such as liver/kidney failure, serious infection etc\n* Allergic to the study drug\n* Had been participated in other clinical trials during the last 3 months prior to study inclusion.\n* Taking Coenzyme Q10, MAO-B inhibitors, or vitamin E, all of which might improve the symptom or slowdown the progression of PD.\n* Taking herbal medicine that can nourish the liver and kidney by TCM standard.\n* Had serious mental disorder and could not describe his/her symptom."}, 'identificationModule': {'nctId': 'NCT00629161', 'briefTitle': 'Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'orgStudyIdInfo': {'id': '2006BAI04A11-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant)', 'type': 'DRUG', 'description': '12 months period of Traditional Chinese Medicinal Mixture per day plus 1 month wash-out period without herbal medicine', 'armGroupLabels': ['A']}, {'name': 'placebo', 'type': 'DRUG', 'description': '12 months period of placebo plus 1 month period without placebo', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Gao, MD', 'role': 'CONTACT'}], 'facility': 'Department of Neurology, Xuanwu hospital, Capital University of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Xiao, MD', 'role': 'CONTACT'}], 'facility': 'Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Canxing Yuan, MD', 'role': 'CONTACT'}], 'facility': 'Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dingfang Cai, MD', 'role': 'CONTACT', 'email': 'doctorcn@hotmail.com'}], 'facility': 'Zhongshan hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200065', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qing Zhan, MD', 'role': 'CONTACT'}], 'facility': 'Tongji Hospital of Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200071', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Liu, MD', 'role': 'CONTACT'}], 'facility': 'Shanghai Chinese Medical Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenguo Liu', 'role': 'CONTACT'}], 'facility': 'Department of Nuerology, Xinhua Hospital, Affiliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200233', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojiang Sun, MD', 'role': 'CONTACT'}], 'facility': "The Sixth People's Hospital, Shanghai Jiaotong University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200437', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Zhao, MD', 'role': 'CONTACT'}], 'facility': 'Department of Neurology, Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liya Han', 'role': 'CONTACT'}], 'facility': "Department of Neurology, The second people's hospital of Wenzhou", 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Dingfang Cai, MD', 'role': 'CONTACT', 'email': 'doctorcn@hotmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dingfang Cai', 'oldOrganization': 'Zhongshan hospital, Fudan University'}}}}