Diabetes Mellitus and Vulvovaginal Candidiasis
Information source: Indian Council of Medical Research
Information obtained from ClinicalTrials.gov on May 09, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Vulvovaginal Candidiasis
Intervention: Fluconazole or boric acid vaginal suppositories (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Indian Council of Medical Research Official(s) and/or principal investigator(s):
Ravinder Goswami, DM, Principal Investigator, Affiliation: All India Institute of Medical Sciences New Delhi, 110029, India
Summary
Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.
Clinical Details
Official title:
Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management
Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab
Secondary outcome: Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 66 Years.
Gender(s): Female.
Criteria:
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 and Contacts
Dr Ravinder Goswami, Delhi 29, India
Additional Information
Starting date:
June 2004
Ending date: April 2006
Last updated: July 17, 2006
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