Monthly Itraconazole Versus Classic Homeopathy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC)
NCT ID: NCT00895453
Last Updated: 2016-11-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
144 participants
INTERVENTIONAL
2000-05-31
2006-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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itraconazole
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).
itraconazole
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)
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.
itraconazole
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)
lactobacillus gasseri
Lactobacillus vaginal tablets monthly given through 6 days
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.
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.
Interventions
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itraconazole
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)
lactobacillus gasseri
Lactobacillus vaginal tablets monthly given through 6 days
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
60 Years
FEMALE
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Vienna Medical School
Principal Investigators
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Armin Witt, MD
Role: PRINCIPAL_INVESTIGATOR
Vienna Medical School
Locations
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Vienna Medical School
Vienna, , Austria
Countries
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Other Identifiers
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134/2000
Identifier Type: -
Identifier Source: org_study_id