Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-29 @ 8:49 PM
Study NCT ID:
NCT01844050
Status:
COMPLETED
Last Update Posted:
2019-06-12
First Post:
2013-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-11', 'studyFirstSubmitDate': '2013-04-22', 'studyFirstSubmitQcDate': '2013-04-27', 'lastUpdatePostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Total score of diabetes symptoms at 4 weeks', 'timeFrame': '0 weeks(baseline), 2 weeks, 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Fasting Blood Glucose at 4 weeks', 'timeFrame': '0 weeks(baseline), 2 weeks, 4 weeks'}, {'measure': 'Change from Baseline blood glucose at 2 hours after meal at 4 weeks', 'timeFrame': '0 weeks(baseline), 2 weeks, 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chinese herbal medicine', 'diabetes symptoms'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms.\n* After the diet and exercise therapy, 7.0mmol/l≤FPG≤11.1mmol/l or 8.0mmol/l\\<2h PG\\<16mmol/l\n* Any type of TCM syndrome, but can be performed within the chosen Chinese herbal medicine.\n* Subject is willing to participate and capable of giving informed consent.\n\nExclusion Criteria:\n\n* Those patients used any drugs for treatment of diabetes within one month.\n* Patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system.\n* Patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month.\n* Women who were pregnant, lactating or planned pregnant.\n* Allergic constitution and has a history of drug allergy.\n* Combined with severe acute or chronic infections.'}, 'identificationModule': {'nctId': 'NCT01844050', 'briefTitle': 'Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai University of Traditional Chinese Medicine'}, 'orgStudyIdInfo': {'id': '06DZ19728-2'}, 'secondaryIdInfos': [{'id': 'S06DZ19728', 'type': 'OTHER', 'domain': 'Shanghai University of TCM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chinese herbal medicine', 'description': 'Individualized Treatment with Chinese herbal', 'interventionNames': ['Drug: Chinese herbal medicine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Individualized Treatment with placebo Chinese herbal which Containing 2% of Chinese herbal medicine.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Chinese herbal medicine', 'type': 'DRUG', 'description': 'According to the traditional Chinese medicine syndrome of subject to make up a prescription within the 35 kinds of chosen Chinese herbal medicine, and the dosage without limitation.', 'armGroupLabels': ['Chinese herbal medicine']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201108', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Kaixian Chen, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Universitu of TCM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Longhua Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Putuo District Center Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}