Clinical Trial: Monthly Itraconazole Versus Classic Homeopathy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Monthly Itraconazole Versus Classic Homeopathy for the Treatment of Recurrent Vulvovaginal Candidiasis: a Randomised Trial

Brief Summary: A prospective study to evaluate the efficacy of classic homeopathic therapy compared to maintenance itraconazole therapy with and without additional exogenous lactobacillus for treatment of recurrent Candida vaginitis.

Detailed Summary:

Objective:

Antimycotics effectively treat sporadic and recurrent vulvovaginal candidiasis (RVVC). Classic homeopathy (CH) is also used to treat this condition. We compared the efficacy of CH and itraconazole in reducing the frequency of RVVC episodes.

Design:

Single-centre, prospective, randomized.

Sample:

One-hundred-and-fifty patients with a history of RVVC and an acute episode of VVC.

Methods:

Women were randomised into 3 groups: itraconazole with lactobacilli (group 1), itraconazole without lactobacilli (group 2) and CH (group 3). Itraconazole treatment of acute infection was followed by a 6-months maintenance regimen with monthly single-day itraconazole (200 mg bid). Thereafter, patients were followed without treatment for 6 months. Women in group 1 were given additional vaginal lactobacilli for six days per month. CH treatment was performed for 12 months.


Sponsor: Medical University of Vienna

Current Primary Outcome: Candida Culture Free After Maintenance Therapy [ Time Frame: 12 months ]

candida culture free (monthly vaginal cultures were obtained)


Original Primary Outcome: Candida Culture Free After Maintenance Therapy [ Time Frame: 12 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medical University of Vienna

Dates:
Date Received: January 16, 2009
Date Started: May 2000
Date Completion:
Last Updated: September 26, 2016
Last Verified: May 2009