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Completed

NCT Number: NCT00353561

Diabetes Mellitus and Vulvovaginal Candidiasis

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Boric

Drug

Gelatin capsules filled with 600 mg of boric acid

Fluconazole

Drug

150 mg oral fluconazole gives once in 14 days

Primary outcomes

  1. 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

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

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Indian Council of Medical Research

Other Gov

Registry information

Official study title

Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jul 18, 2006
Registry last updated
May 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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