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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00353561
Other study ID # RHN/Adhoc/23/2003-2004
Secondary ID
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


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
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