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Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1, Boric acid | Active Comparator | 600 mg vaginal pessaries for 14 days |
|
| 2, Fluconazole | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boric | Drug | Gelatin capsules filled with 600 mg of boric acid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ravinder Goswami, DM | All India Institute of Medical Sciences New Delhi, 110029, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Ravinder Goswami | Delhi | National Capital Territory of Delhi | 29 | India |
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| Label | URL |
|---|---|
| PMID: 17692922 and 17259500, J Infection 2007 and Diabetes Care 2007 | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C032688 | boric acid |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fluconazole |
| Drug |
150 mg oral fluconazole gives once in 14 days |
|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014848 | Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |