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

Primary Purpose

Vulvovaginal Candidiasis

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
itraconazole
lactobacillus gasseri
classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiasis focused on measuring recurrent vulvovaginal candidiasis, itraconazole, classic homeopathy

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Vienna Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

itraconazole

itraconazole + lactobacilli agent

classic homeopathy (CH)

Arm Description

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

6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.

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.

Outcomes

Primary Outcome Measures

Candida Culture Free After Maintenance Therapy
candida culture free (monthly vaginal cultures were obtained)

Secondary Outcome Measures

Full Information

First Posted
January 16, 2009
Last Updated
September 26, 2016
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00895453
Brief Title
Monthly Itraconazole Versus Classic Homeopathy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC)
Official Title
Monthly Itraconazole Versus Classic Homeopathy for the Treatment of Recurrent Vulvovaginal Candidiasis: a Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis
Keywords
recurrent vulvovaginal candidiasis, itraconazole, classic homeopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
itraconazole
Arm Type
Active Comparator
Arm Description
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).
Arm Title
itraconazole + lactobacilli agent
Arm Type
Active Comparator
Arm Description
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.
Arm Title
classic homeopathy (CH)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
itraconazole
Intervention Description
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)
Intervention Type
Drug
Intervention Name(s)
lactobacillus gasseri
Intervention Description
Lactobacillus vaginal tablets monthly given through 6 days
Intervention Type
Drug
Intervention Name(s)
classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)
Intervention Description
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 Outcome Measure Information:
Title
Candida Culture Free After Maintenance Therapy
Description
candida culture free (monthly vaginal cultures were obtained)
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Witt, MD
Organizational Affiliation
Vienna Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Medical School
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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