Diabetes Mellitus and Vulvovaginal Candidiasis

Phase 3

Completed

• Conditions: Diabetes Mellitus; Vulvovaginal Candidiasis
• Interventions: Drug: Boric; Drug: Fluconazole

• Registration Number: NCT00353561
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2006-07-17
• Study First Submitted QC: 2006-07-17
• Study First Posted: 2006-07-18
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-21
• Last Update Posted: 2008-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1, Boric acid	Boric	600 mg vaginal pessaries for 14 days
2, Fluconazole	Fluconazole	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion	15 days

Trial Locations

Locations (1)

Dr Ravinder Goswami; 🇮🇳 Delhi, India