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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00895453
First received: January 16, 2009
Last updated: May 7, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


Condition Intervention
Vulvovaginal Candidiasis
 Drug: itraconazole
Drug: lactobacillus gasseri
Drug: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monthly Itraconazole Versus Classic Homeopathy for the Treatment of Recurrent Vulvovaginal Candidiasis: a Randomised Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Candida Culture Free After Maintenance Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: May 2000
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: itraconazole
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).
 Drug: itraconazole
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)
Active Comparator: itraconazole + lactobacilli agent
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.
 Drug: itraconazole
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)
Drug: lactobacillus gasseri
Lactobacillus vaginal tablets monthly given through 6 days
Active Comparator: classic homeopathy (CH)
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.
 Drug: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895453

Locations
Austria
Vienna Medical School
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Armin Witt, MD Vienna Medical School
  More Information

No publications provided

Responsible Party: Armin Witt, Vienna Medical School
ClinicalTrials.gov Identifier: NCT00895453     History of Changes
Other Study ID Numbers: 134/2000
Study First Received: January 16, 2009
Results First Received: January 16, 2009
Last Updated: May 7, 2009
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Vienna:
recurrent vulvovaginal candidiasis
itraconazole
classic homeopathy

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Itraconazole
Hydroxyitraconazole
Iron
 14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013