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Sponsored by: |
Indian Council of Medical Research |
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Information provided by: | Indian Council of Medical Research |
ClinicalTrials.gov Identifier: | NCT00353561 |
Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus Vulvovaginal Candidiasis |
Drug: Boric Drug: Fluconazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management |
Enrollment: | 100 |
Study Start Date: | June 2004 |
Study Completion Date: | April 2006 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1, Boric acid: Active Comparator
600 mg vaginal pessaries for 14 days
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Drug: Boric
Gelatin capsules filled with 600 mg of boric acid
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2, Fluconazole |
Drug: Fluconazole
150 mg oral fluconazole gives once in 14 days
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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.
Ages Eligible for Study: | 18 Years to 66 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India | |
Dr Ravinder Goswami | |
Delhi, India, 29 |
Principal Investigator: | Ravinder Goswami, DM | All India Institute of Medical Sciences New Delhi, 110029, India |
Responsible Party: | All India Institute of Medical Sciences, New Delhi 110029 ( Ravinder Goswami ) |
Study ID Numbers: | RHN/Adhoc/23/2003-2004 |
Study First Received: | July 17, 2006 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00353561 |
Health Authority: | India: Institutional Review Board |
Fluconazole Vulvovaginitis Metabolic Diseases Candidiasis Candidiasis, Vulvovaginal Clotrimazole Miconazole Vaginitis Tioconazole |
Diabetes Mellitus Endocrine System Diseases Vaginal Diseases Genital Diseases, Female Mycoses Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Vulvar Diseases |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Vulvitis Pharmacologic Actions |