Status:

COMPLETED

Diabetes Mellitus and Vulvovaginal Candidiasis

Lead Sponsor:

Indian Council of Medical Research

Conditions:

Diabetes Mellitus

Vulvovaginal Candidiasis

Eligibility:

FEMALE

18-66 years

Phase:

PHASE3

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2006

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00353561

Start Date

June 1 2004

End Date

April 1 2006

Last Update

May 22 2008

Active Locations (1)

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1

Dr Ravinder Goswami

Delhi, National Capital Territory of Delhi, India, 29