Diabetes Mellitus and Vulvovaginal Candidiasis

• Sponsor: Indian Council of Medical Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT00353561
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Vulvovaginal Candidiasis	Drug: Boric; Drug: Fluconazole	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management
• Study Start Date: Jun 1, 2004
• Actual Primary Completion Date: Apr 1, 2006
• Actual Study Completion Date: Apr 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1, Boric acid 600 mg vaginal pessaries for 14 days	Drug: Boric; Gelatin capsules filled with 600 mg of boric acid
Other: 2, Fluconazole	Drug: Fluconazole; 150 mg oral fluconazole gives once in 14 days

Outcome Measures

Primary Outcome Measures

1. 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

1. Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion [15 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 66 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr Ravinder Goswami	Delhi		India	29

Sponsors and Collaborators

• Indian Council of Medical Research

Investigators

• Principal Investigator: Ravinder Goswami, DM, All India Institute of Medical Sciences New Delhi, 110029, India

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00353561
• Other Study ID Numbers: RHN/Adhoc/23/2003-2004
• First Posted: Jul 18, 2006
• Last Update Posted: May 22, 2008
• Last Verified: May 1, 2008

• Additional relevant MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Diabetes Mellitus; Fluconazole

Study Results

No Results Posted as of May 22, 2008