Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-26 @ 7:41 PM
Study NCT ID:
NCT00904592
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2008-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 480}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-20', 'studyFirstSubmitDate': '2008-12-24', 'studyFirstSubmitQcDate': '2009-05-18', 'lastUpdatePostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Symptoms scores of TCM', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetic retinopathy', 'traditional chinese medicine'], 'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/19802544?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=1', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '1. Title: A Study on TCM comprehensive protocol of Prevention and Control in Diabetic Retinopathy.\n2. Objectives of study: To evaluate the Intervention effect of integrate control protocol on reducing the incidence rate of proliferative diabetic retinopathy, PRP and MVL. Then produce a high performance, optimize, convenient, applicable and demonstrated protocol of integrate control with Intervention of TCM and west medicine.\n3. Study Type: Interventional\n4. Study Design: Multi-center, Randomized, Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Positive controlled clinical study.\n5. Sample size: 480 subjects , divided into test and control groups equally.\n6. Primary endpoint: incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation', 'detailedDescription': '1. Primary outcome:\n\n * proliferative diabetic retinopathy\n * panretinal photocoagulation\n2. Secondary outcome:\n\n * Vision, Funduscopy, Fundus photograph\n * Fundus fluorescein angiography\n * Visual Electrophysiology:FERG、OPs、PVEP.\n * Optical coherence tomography.\n * Symptoms scores of TCM.\n * The M0S short-form-36 heaIth survey(SF-36).\n * Visual Function Questionnaire-25(VFQ-25).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with diabetes mellitus.\n* Diagnosed with non-proliferative diabetic retinopathy, including moderate and severe diabetic retinopathy\n* and corrected VA≥45 letters(ETDRS), equivalent the decimal value of 0.16(20/125).\n* Diagnosed with the syndrome and signs of TCM.\n* HbA1C≤8.0%.\n* Ages ranged from 35 to 75 years.\n* Joined in the test voluntarily and signed the Informed consent by GCP regulation.\n\nExclusion Criteria:\n\n* Complicating severe vitreous hemorrhage, or requiring laser and vitrectomy treatment.\n* The patients who have been received the therapy of Retina laser photocoagulation.\n* The patients whose dioptric media is so turbid that hard to evaluate the fundus picture.\n* DMKA or other acute metabolic disturbance, or complicating severe acute infection within a month.\n* Combined with other severe Diabetic complication.\n* Having any allergic reaction to some drugs, food and pollen etc. or hypersensitiveness\n* Pregnant or breast feeding.\n* combined with primarily severe diseases such as cardiovascular, hepatic，renal illness ,hemopoietic system disease, and psychosis.\n* Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.\n* Participated in other clinical trial within 3 month.'}, 'identificationModule': {'nctId': 'NCT00904592', 'briefTitle': 'A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Chengdu University of Traditional Chinese Medicine'}, 'officialTitle': 'A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy', 'orgStudyIdInfo': {'id': '2006BAI04A0401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Qi ming granula', 'description': 'Study group(combined therapy with Intervention of TCM): Basic therapy ＆ treating both on deficiency and stasis of blood.\n\n1. Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management, exercise and education.\n2. Qi ming granula, Usage: 4.5g，po，tid.', 'interventionNames': ['Drug: Qi ming granula']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo comparator', 'description': 'Control group: Basic therapy ＆ placebo\n\n1. Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management , exercise and education.\n2. placebo,Usage: 4.5g，po，tid', 'interventionNames': ['Drug: Placebo Comparator']}], 'interventions': [{'name': 'Qi ming granula', 'type': 'DRUG', 'otherNames': ['QM'], 'description': 'Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event', 'armGroupLabels': ['Qi ming granula']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'otherNames': ['PC'], 'description': 'Control group: Basic therapy ＆ placebo\n\n1. Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management , exercise and education.\n2. placebo,Usage: 4.5g，po，tid', 'armGroupLabels': ['placebo comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610075', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chengdu University of TCM', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Junguo Duan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chengdu University of TCM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}