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Trial record 19 of 22 for:    "Vulvitis" | "Steroid Synthesis Inhibitors"

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

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ClinicalTrials.gov Identifier: NCT00895453
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : May 8, 2009
Last Update Posted : November 11, 2016
Sponsor:
Information provided by:
Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Vulvovaginal Candidiasis Drug: itraconazole Drug: lactobacillus gasseri Drug: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monthly Itraconazole Versus Classic Homeopathy for the Treatment of Recurrent Vulvovaginal Candidiasis: a Randomised Trial
Study Start Date : May 2000
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Candida Culture Free After Maintenance Therapy [ Time Frame: 12 months ]
    candida culture free (monthly vaginal cultures were obtained)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895453


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

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Responsible Party: Armin Witt, Vienna Medical School
ClinicalTrials.gov Identifier: NCT00895453     History of Changes
Other Study ID Numbers: 134/2000
First Posted: May 8, 2009    Key Record Dates
Results First Posted: May 8, 2009
Last Update Posted: November 11, 2016
Last Verified: May 2009
Keywords provided by Medical University of Vienna:
recurrent vulvovaginal candidiasis
itraconazole
classic homeopathy
Additional relevant MeSH terms:
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Vulvitis
Steroid Synthesis Inhibitors
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvar Diseases
Iron
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Trace Elements
Micronutrients
Nutrients
Growth Substances