Diabetes Mellitus and Vulvovaginal Candidiasis

This study has been completed.
Sponsor:
Information provided by:
Indian Council of Medical Research
ClinicalTrials.gov Identifier:
NCT00353561
First received: July 17, 2006
Last updated: May 21, 2008
Last verified: May 2008

July 17, 2006
May 21, 2008
June 2004
April 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab
Complete list of historical versions of study NCT00353561 on ClinicalTrials.gov Archive Site
Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion
 
 
 
Diabetes Mellitus and Vulvovaginal Candidiasis
Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Vulvovaginal Candidiasis
  • Drug: Boric
    Gelatin capsules filled with 600 mg of boric acid
  • Drug: Fluconazole
    150 mg oral fluconazole gives once in 14 days
  • Active Comparator: 1, Boric acid
    600 mg vaginal pessaries for 14 days
    Intervention: Drug: Boric
  • 2, Fluconazole
    Intervention: Drug: Fluconazole
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2006
April 2006   (final data collection date for primary outcome measure)

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.
Female
18 Years to 66 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00353561
RHN/Adhoc/23/2003-2004
 
Ravinder Goswami, All India Institute of Medical Sciences, New Delhi 110029
Indian Council of Medical Research
 
Principal Investigator: Ravinder Goswami, DM All India Institute of Medical Sciences New Delhi, 110029, India
Indian Council of Medical Research
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP