Diabetes Mellitus and Vulvovaginal Candidiasis

NCT00353561 | Completed Phase 3

• 1 other identifier: RHN/Adhoc/23/2003-2004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus; Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion

  15 days

Study Arms (2)

1, Boric acid

ACTIVE COMPARATOR

600 mg vaginal pessaries for 14 days

Drug: Boric

2, Fluconazole

OTHER

Drug: Fluconazole

Interventions

Boric DRUG

Gelatin capsules filled with 600 mg of boric acid

1, Boric acid

Fluconazole DRUG

150 mg oral fluconazole gives once in 14 days

2, Fluconazole

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indian Council of Medical Research: lead

Study Sites (1)

Dr Ravinder Goswami

Delhi, National Capital Territory of Delhi, 29, India

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus; Candidiasis, Vulvovaginal

Interventions

boric acid; Fluconazole

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ravinder Goswami, DM

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 17, 2006
• First Posted: July 18, 2006
• Study Start: June 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: May 22, 2008

Record last verified: 2008-05

Locations

IN (1)