Diabetes Mellitus, Vulvovaginal Candidiasis
Conditions
Brief summary
Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.
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.
Interventions
DRUGBoric
Gelatin capsules filled with 600 mg of boric acid
DRUGFluconazole
150 mg oral fluconazole gives once in 14 days
Sponsors
Indian Council of Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 66 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* Patients with vaginal discharge in whom Candida growth was not detected on fungal culture were excluded. * Subjects also excluded were those with pregnancy, * Sexually inactive girls, * Age \> 65 years, renal failure and steroid therapy. * Patients who did not give consent for pelvic examination, * 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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion | 15 days |
Countries
India
Outcome results
None listed