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Completed

NCT Number: NCT00895453

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

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.

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Key information

Conditions

Vulvovaginal Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vienna Medical School

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years, premenopausal
  • Negative pregnancy test
  • Signed informed consent
  • At least 4 Episodes of Candidiasis within the last year
  • Candida detectable by culture
  • Negative Hepatitis- and HIV-Serology
  • No Allergy to Itraconazole

Exclusion criteria

  • Under 18 years

Treatment and study plan

Itraconazole

Drug

6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)

lactobacillus gasseri

Drug

Lactobacillus vaginal tablets monthly given through 6 days

classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)

Drug

CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.

Primary outcomes

  1. Candida Culture Free After Maintenance Therapy

    Time frame: 12 months

    candida culture free (monthly vaginal cultures were obtained)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
May 8, 2009
Registry last updated
Nov 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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