Diabetes Mellitus and Vulvovaginal Candidiasis
This study has been completed.
Sponsor:
Indian Council of Medical Research
Information provided by:
Indian Council of Medical Research
ClinicalTrials.gov Identifier:
NCT00353561
First received: July 17, 2006
Last updated: May 21, 2008
Last verified: May 2008
Tracking Information | |||||
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First Received Date ICMJE | July 17, 2006 | ||||
Last Updated Date | May 21, 2008 | ||||
Start Date ICMJE | June 2004 | ||||
Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab [ Time Frame: 15 days ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab | ||||
Change History | Complete list of historical versions of study NCT00353561 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion [ Time Frame: 15 days ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE |
Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Diabetes Mellitus and Vulvovaginal Candidiasis | ||||
Official Title ICMJE | Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management | ||||
Brief Summary | Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis. |
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 100 | ||||
Completion Date | April 2006 | ||||
Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years to 66 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | India | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00353561 | ||||
Other Study ID Numbers ICMJE | RHN/Adhoc/23/2003-2004 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Ravinder Goswami, All India Institute of Medical Sciences, New Delhi 110029 | ||||
Study Sponsor ICMJE | Indian Council of Medical Research | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Indian Council of Medical Research | ||||
Verification Date | May 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |