Back to resultsDiabetes Mellitus and Vulvovaginal Candidiasis
Primary Purpose
Diabetes Mellitus, Vulvovaginal Candidiasis
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Boric
Fluconazole
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
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.
Sites / Locations
- Dr Ravinder Goswami
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
1, Boric acid
2, Fluconazole
Arm Description
600 mg vaginal pessaries for 14 days
Outcomes
Primary Outcome Measures
Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab
Secondary Outcome Measures
Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion
Full Information
NCT ID
NCT00353561
First Posted
July 17, 2006
Last Updated
May 21, 2008
Sponsor
Indian Council of Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT00353561
Brief Title
Diabetes Mellitus and Vulvovaginal Candidiasis
Official Title
Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Indian Council of Medical Research
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Vulvovaginal Candidiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1, Boric acid
Arm Type
Active Comparator
Arm Description
600 mg vaginal pessaries for 14 days
Arm Title
2, Fluconazole
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Boric
Intervention Description
Gelatin capsules filled with 600 mg of boric acid
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Description
150 mg oral fluconazole gives once in 14 days
Primary Outcome Measure Information:
Title
Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion
Time Frame
15 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravinder Goswami, DM
Organizational Affiliation
All India Institute of Medical Sciences New Delhi, 110029, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Ravinder Goswami
City
Delhi
ZIP/Postal Code
29
Country
India
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/sites/entrez
Description
PMID: 17692922 and 17259500, J Infection 2007 and Diabetes Care 2007
Learn more about this trial
Diabetes Mellitus and Vulvovaginal Candidiasis
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