Diabetes Mellitus and Vulvovaginal Candidiasis

Indian Council of Medical Research (ICMR)

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus

Vulvovaginal Candidiasis

Treatments

Drug: Fluconazole

Drug: Boric

Study type

Interventional

Funder types

Other

Identifiers

NCT00353561

RHN/Adhoc/23/2003-2004

Details and patient eligibility

About

Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.

Full 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.

Enrollment

100 patients

Sex

Female

Ages

18 to 66 years old

Volunteers

No Healthy Volunteers

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.