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Diabetes Mellitus and Vulvovaginal Candidiasis

NCT ID: NCT00353561

Last Updated: 2008-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus Vulvovaginal Candidiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1, Boric acid

600 mg vaginal pessaries for 14 days

Group Type ACTIVE_COMPARATOR

Boric

Intervention Type DRUG

Gelatin capsules filled with 600 mg of boric acid

2, Fluconazole

Group Type OTHER

Fluconazole

Intervention Type DRUG

150 mg oral fluconazole gives once in 14 days

Interventions

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Boric

Gelatin capsules filled with 600 mg of boric acid

Intervention Type DRUG

Fluconazole

150 mg oral fluconazole gives once in 14 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Indian Council of Medical Research

OTHER_GOV

Sponsor Role lead

Responsible Party

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All India Institute of Medical Sciences, New Delhi 110029

Principal Investigators

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Ravinder Goswami, DM

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences New Delhi, 110029, India

Locations

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Dr Ravinder Goswami

Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Related Links

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http://www.ncbi.nlm.nih.gov/sites/entrez

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

Other Identifiers

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RHN/Adhoc/23/2003-2004

Identifier Type: -

Identifier Source: org_study_id