Diabetes Mellitus and Vulvovaginal Candidiasis

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353561
• Other study ID #: RHN/Adhoc/23/2003-2004
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2006
• Last updated: May 21, 2008
• Start date: June 2004
• Est. completion date: April 2006

Study information

• Verified date: May 2008
• Source: Indian Council of Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 66 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Diabetes Mellitus
• Vulvovaginal Candidiasis

Intervention

Drug:
• Boric
Gelatin capsules filled with 600 mg of boric acid
• Fluconazole
150 mg oral fluconazole gives once in 14 days

Locations

Country	Name	City	State
India	Dr Ravinder Goswami	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Indian Council of Medical Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab		15 days	Yes
Secondary	Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion		15 days	Yes

External Links

•   PMID: 17692922 and 17259500, J Infection 2007 and Diabetes Care 2007