Diabetes Mellitus and Vulvovaginal Candidiasis

Indian Council of Medical Research100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Diabetes Mellitus Vulvovaginal Candidiasis

Interventions

BoricDRUG

Gelatin capsules filled with 600 mg of boric acid

FluconazoleDRUG

150 mg oral fluconazole gives once in 14 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 66 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dr Ravinder Goswami

Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

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

Secondary Outcomes

Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion

Time frame: 15 days

Data from ClinicalTrials.gov

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