Diabetes Mellitus and Vulvovaginal Candidiasis

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes Mellitus, Vulvovaginal Candidiasis

Intervention / Treatment
-----------------
* Drug: Boric
* Drug: Fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1, Boric acid<br>600 mg vaginal pessaries for 14 days | Drug: Boric<br>* Gelatin capsules filled with 600 mg of boric acid<br>|
| Other: 2, Fluconazole<br> | Drug: Fluconazole<br>* 150 mg oral fluconazole gives once in 14 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion |  | 15 days |