Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-28 @ 2:42 AM
Study NCT ID:
NCT00353561
Status:
COMPLETED
Last Update Posted:
2008-05-22
First Post:
2006-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetes Mellitus and Vulvovaginal Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D002181', 'term': 'Candidiasis, Vulvovaginal'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014848', 'term': 'Vulvovaginitis'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014847', 'term': 'Vulvitis'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C032688', 'term': 'boric acid'}, {'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-21', 'studyFirstSubmitDate': '2006-07-17', 'studyFirstSubmitQcDate': '2006-07-17', 'lastUpdatePostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': 'Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion', 'timeFrame': '15 days'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Vulvovaginal Candidiasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/sites/entrez', 'label': 'PMID: 17692922 and 17259500, J Infection 2007 and Diabetes Care 2007'}]}, 'descriptionModule': {'briefSummary': 'Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.', 'detailedDescription': 'A high proportion of vulvovaginal candidiasis is due to C.glabrata that responds poorly to fluconazole therapy. We assessed the clinical relief and mycological cure in response to oral fluconazole and boric acid suppositories in patients with diabetes mellitus and vulvovaginal candidiasis given in a Randomized trial. Fluconazole was given in standard oral single dose (150 mg) fluconazole and boric acid vaginal suppositories was given in dose of 600 mg/daily for 14 uninterrupted days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients with diabetes mellitus attending Endocrine OPD of All India Institute of Medical Sciences and in whom the diagnosis of vulvovaginal candidiasis was based on presence of clinical signs and symptoms and growth of Candida species on culture of high vaginal swab (HVS).\n\nExclusion Criteria:\n\n* Patients with vaginal discharge in whom Candida growth was not detected on fungal culture were excluded.\n* Subjects also excluded were those with pregnancy,\n* Sexually inactive girls,\n* Age \\> 65 years, renal failure and steroid therapy.\n* Patients who did not give consent for pelvic examination,\n* Those who were treated for any kind of vaginal discharge during the past three months and who did not comply with boric acid therapy or did not report on 15th day for repeat examination excluded.'}, 'identificationModule': {'nctId': 'NCT00353561', 'briefTitle': 'Diabetes Mellitus and Vulvovaginal Candidiasis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Indian Council of Medical Research'}, 'officialTitle': 'Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management', 'orgStudyIdInfo': {'id': 'RHN/Adhoc/23/2003-2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1, Boric acid', 'description': '600 mg vaginal pessaries for 14 days', 'interventionNames': ['Drug: Boric']}, {'type': 'OTHER', 'label': '2, Fluconazole', 'interventionNames': ['Drug: Fluconazole']}], 'interventions': [{'name': 'Boric', 'type': 'DRUG', 'description': 'Gelatin capsules filled with 600 mg of boric acid', 'armGroupLabels': ['1, Boric acid']}, {'name': 'Fluconazole', 'type': 'DRUG', 'description': '150 mg oral fluconazole gives once in 14 days', 'armGroupLabels': ['2, Fluconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29', 'city': 'Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Dr Ravinder Goswami', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}], 'overallOfficials': [{'name': 'Ravinder Goswami, DM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'All India Institute of Medical Sciences New Delhi, 110029, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indian Council of Medical Research', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Ravinder Goswami', 'oldOrganization': 'All India Institute of Medical Sciences, New Delhi 110029'}}}}